Effect of probiotic supplement in tuberculosis patients
- Conditions
- Tuberculosis of lung,
- Registration Number
- CTRI/2023/11/059867
- Lead Sponsor
- Sri Siddhartha Medical college
- Brief Summary
**PROPOSED ABSTRACT &METHODOLOGY**
**By Dr.SheebaNasrullah Malik**
**Personal details :**
**Name- Dr.Sheeba Malik**
**Email-** [**maliksheeba1@gmail.com**](mailto:maliksheeba1@gmail.com)
**Course- MD (Respiratory Medicine)**
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| **B1. What is the current title**
“To compare and determine the effect of probiotic (lactic acid bacilli) supplementation on inflammatory biomarkers during intensive treatment phase of Pulmonary tuberculosis: A prospective studyâ€
**B2. Brief overall description of your research**
Tuberculosis is a multi-faceted communicable disease caused by Mycobacterium tuberculosis, one of the foremost causes of death globally. Until the coronavirus (COVID-19) pandemic, TB was the leading cause of death from a single infectious agent, ranking above HIV/AIDS.
An estimated 10.6 million people were affected by TB globally in 2021. The TB incidence rate (new cases per 100 000 population per year) is estimated to have increased by 3.6% between 2020 and 2021. In 2021, there were an estimated 1.4 million deaths among HIV-negative people and 187 000 deaths among HIV-positive people, globally. Some of the highest TB burden countries accounted for 87% of all estimated incident cases globally, and eight of these countries accounted for more than two thirds of the global total: India (28%), Indonesia (9.2%), China (7.4%), the Philippines (7.0%), Pakistan (5.8%), Nigeria (4.4%), Bangladesh (3.6%) and the Democratic Republic of the Congo (2.9%) (1) .
The epidemiology of Tuberculosis is being analysed for years now. Presently, we use a combination of four first-line antimycobacterial drugs (isoniazid, rifampicin, ethambutol, and pyrazinamide) are used to treat TB clinically (2) . All four drugs are prescribed to patients during the intensive phase—the first 2 months of TB treatment (3) . Clinical treatment provides favourable theraupatic effects. However, new interventions are sought every now and then to strengthen the already existing treatment modalities. Also, to decrease the pill burden and decrease complexity, in order to improve adherence.
Latest studies in microbiota explorations have led to an improved knowledge of the communities of commensal microorganisms within the human body. Among the relevant inter-organ connections, the gut–lung axis (GLA) remains opus. The lung microbiota represents a significant biomass inhabiting the respiratory tract. Its composition is based on the microbial colonization from the oropharynx and upper respiratory tract via salivary micro-inhalations, on the host elimination abilities (especially coughing and mucociliary clearance), on interactions with the host immune system, and on local conditions for microbial proliferation, such as pH or oxygen concentration (4) (5) . The lung microbiota viz-a-viz gut microbiome is now regarded as a linchpin in the physiopathology and outcomes of numerous respiratory diseases (6)
Growing clinical evidences reveal that targeting the gut–lung microbiota axis may play a therapeutic role in respiratory infections. Newer strategies, like use of probiotics, for improvement of outcomes in respiratory infections by modulating inflammatory responses are considered (7) . Probiotics are â€living non-pathogenic microorganisms†that when administered in adequate amounts, confer a health benefit on the host (8) . Studies have indicated that the consumption of probiotics can regulate metabolites and inflammatory cytokines (9) (10). A recent study showed that daily probiotic, L.casei, supplementation during the intensive phase of TB treatment modulates metabolites and inflammatory cytokines (11) . However, an extensive literature search indicated that very limited studies have focused on the effects of probiotics on the plasma inflammatory biomarkers receiving TB treatment. Hence a study is needed to assess role of probiotics and its impact in the disease course of Tuberculosis.
**B3. Mainresearch questions and aims**
**AIMOF THE STUDY**
“To study the effect of probioticsupplementation on inflammatory biomarkers during intensive treatment phase ofPulmonary tuberculosisâ€
**OBJECTIVES OF THE STUDY**
· Toanalyse impact of probiotic supplementation on inflammatory biomarkers like CRP(C-reactive protein), ESR ( erythrocyte sedimentation rate), TLC( Totalleucocyte count), NEU( neutrophil counts) , MPV( mean platelet volume) in intensive treatment phase ofTuberculosis.
· Toassess role of probiotics in the duration of sputum culture conversion
· Toassess effect of probiotics on gastric side-effects of anti-tuberculosistreatment
· Toassess role of probiotics in overall clinical improvement for TB patientstaking treatment
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| **Section C. Participants Details**
| **C1. What age groups will be recruited?**
Newly diagnosed pulmonary TB patients, aged 18-65 years.
| **C2. Will you be recruiting any of the following?**
Students–no
Hostel mates -no
Psychiatric disabilities -no
Friends or family-no
Will not recruit from any of the above – Yes
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| **Section D. Proposed methodology and data collection**
| **D1. Brief methodology :**
**1.1 SOURCE OF DATA :**
The study participants/ subjects – Newly diagnosed Pulmonary Tuberculosis ( microbiologically or radiologically- WHO diagnostic criteria) attending various department of the hospital as well as the district TB centre
**1.2 PLACE OF STUDY :**
Sri Siddhartha medical college, Tumkur
District TB centre, Tumkur
**1.3 STUDY DESIGN :**
Randomised trial
**1.4 SAMPLE SIZE:**
**Sample Size:** The sample size is calculated based on the parent study done by **L Jiang et al.: Lactobacillus casei modulates inflammatory cytokines and metabolites during tuberculosis treatment: A post hoc randomized controlled trial.**
For Analysis of variance, assuming a significance level of 0.05(α), power of 0.80(1-β), mean±SD of TNF (pg/ml) in Control, Low-dose and high dose group are 0.91±0.36, 0.88±0.18 and 0.60±0.36 respectively, the sample size will **78** which is calculated by **G\*Power 3.1.9.7** software. Standard deviation within each group is equal to 0.3883 which was calculated by the formula
**1****.5 SAMPLING METHOD** **:**
All participants will be chosen during the intensive treatment phase. They will be randomly allocated to control and test groups. The allocation sequence will be generated by an independent investigator using an online randomization generator ([http://www.randomization.com](http://www.randomization.com/)). The study will be an open-label study, and allocation will be unmasked
.
**1.6 STUDYPERIOD** : 12 months
**1.7 INCLUSIONCRITERIA :**
· Newly diagnosed Pulmonary TB patients, aged18-65 years ( as per WHO diagnostic criteria)
· Writtenconsent from the patien**t**
**1.8 EXCLUSIONCRITERIA:**
· Patientsof Extrapulmonary TB
· Pregnantwomen
· Immunocompromisedpatients and patients on immunocompromised agents
· Patients withcomorbidities like cardiovasculardiseases (Hypetension, Ischaemic heart diseases, Cardiomyopathies),Diabetes, gastrointestinal disease,liver malfunction, tumor, severe mental or psychological illness, or cognitiveimpairment
· Theuse of probiotic supplementation within the previous 2 months.
· Noinformed consent
**D2. METHODSOF COLLECTION OF DATA**
The details of tuberculosispatients will be obtained from various departments of the hospital and alsoDistrict TB unit. All the patients who meet our inclusion and exclusioncriteria will be explained about the study and written informed consent will beobtained. All the details related to the study will be collected directly byinterviewing the patients in various departments of the hospital as well asdistrict tuberculosis centre. Details would also be collected from theirinvestigation reports.
The information will be collectedas per pre-designed structured data collection proforma.
Then the participants will berandomly located to test and controlgroups
Socio-demographic details and relevant anthropometricmeasurements of the participants will also be collected as detailed in theclinical proforma. CBC with ESR will be done at the start of the therapy. Theresults will be noted.
Subsequently, the test groups will be started onprobiotic supplementation i.e Lactic acid bacilli (>120 million spores) for8 weeks during the course of intensiveTB therapy
Patients will be followed up at the end of intensivephase. Results of CBC with ESR and sputum conversion at end of intensive phaseand end of treatment will be noted to analyze the outcome of TB. Details ofother investigations done during the course of treatment will be recorded.Compliance will be assesed
This would help in assesing the role of probiotics inmodulation of inflammatory biomarkers in TB
**Ethicalconsideration:** The study will be submittedfor ethical approval from institutional ethics committee. Informed writtenconsent will be obtained from all the participants after providing detailedinformation on objectives of the study, risks and benefits involved andvoluntary nature of participation. The confidentiality of the studyparticipants will be maintained throughout the study.
**D3. Briefly explain the statistical methods**
Thechi-square test and Kruskal–Wallis H test will be adopted for an analysis of baselinecharacteristics of the study population. Inflammatory biomarkers data willbe log transformed and analyzed withANOVA. Peak intensities of biomarkers will be analyzed with a nonparametrictest (p<0.05) with a Dunn’s multiple comparisons test conducted betweengroups. Mass spectrometry data will be further processed through normalization,scaling, filtering, and statistical analysis using MetaboAnalyst 5.0 . Theorthogonal partial least squares discrimination analysis (OPLS-DA) model willbe used to perform analysis between groups with a permutation test to assessthe risk of overfitting the model. Inflammatory biomarkers concentrations and a correlation heat map willbe illustrated using Graphpad Prism 8.0.2 software. The chi-square test, Kruskal–WallisH test, and ANOVA will be conducted with SPSS 26.0.
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| **Section E. Risks and benefits**
| **E1. Is there any likelihood of significant risk or harm to the rights and wellbeing of participants?**
No
| **E2. How might your research benefit participants?**
The study will help to assess role of probiotics in modulating inflammatory biomarkers in TB patients. Consequently, helping to assess probiotics as add-on therapy to strengthen the current therapy for TB and to improve the clinical outcome of the disease, viz-a-viz gut health of the patient.
**E3. ANY INVESTIGATIONS REQUIRED? IF SO PLEASE DESCRIBE:**
Yes
The investigations that will be conducted are all part of workup for a patient. The following investigations are conducted:
1. CBC
2. ESR
**E4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?**
Received
**CLINICAL PROFORMA**
**Name:**
Hospital Id:
**Age(years): Gender:**
**EducationalQualification:**
**TBNotification No:**
**Clinicalmanifestations**
**Dateof Sputum Positive : Y/N**
**Dateof start of ATT :**
**Probioticsstarted :**
**PAST HISTORY:**
**TB: Y/N**
**Diabetes Mellitus: Y/N**
**HIV:**
**FAMILY HISTORY:**
**TB contact:**
**PERSONAL HISTORY:**
**Diet:**
**Smoking: current/former/non-smoker**
**Alcohol intake: current/former/non-alcoholic**
**MENSTRUAL/OBSTRETIC HISTORY:**
**SOCIOECONOMIC STATUS:**
**Education:**
**Occupation:**
**Family monthly income**
**KS score:**
**Family composition**
**Housing:**
**Water supply:**
**General Physical Examination:**
**Height: Weight: BMI:**
**SYSTEMICEXAMINATION:**
**Anyextrapulmonary manifestation of TB: Y/N**
**Ifyes, region:**
**INVESTIGATION:**
**CBCparameters at the start &end of therapy**
**ESRat the start & end of therapy**
**SPUTUMAFB:**
**CBNAAT:**
**CXR:**
**OTHERSRELEVANT: Y/N SPECIFY:**
**Clinicallydiagnosed TB:**
**Sputumconversion: Yes/ No**
**Complaintsduring the course of Treatment:**
**Outcomeof patient: Cured / Treatment failure / Relapse**
**Transitionto Drug Resistance TB:**
**Mortality:**
**Signature of the Supervisor (Dr. B G SAROJA)**
**Signature of investigator : Dr. Sheeba Nasrullah Malik**
**SRI SIDDHARTHA MEDICAL COLLEGE**
**AGALAKOTE, B.H. ROAD,TUMKUR-572107**
**INFORMED CONSENT FORTHE PATIENTS**
**NAME OF INVESTIGATOR**:
DR SHEEBA NASRULLAH MALIK
POST GRADUATE STUDENT
DEPARTMENT OF RESPIRATORY MEDICINE
Informed consent form is for patients who will beattending inpatient and outpatient departments of SSMC hospital and districttuberculosis centre and who we are inviting to participate in the research.
The title of my study is ““To compare and determine the effect of probiotic (lactic acidbacilli) supplementation on inflammatorybiomarkers during intensive treatment phase of Pulmonary tuberculosis : Aprospective studyâ€
**Name of organization**: Sri Siddhartha Medical College and Hospital**.** Thisinformed consent form has two parts:
· Informationsheet (to share information about the research with you)
· Certificateof consent (for signatures if you agree to take part)
You will be given a copy of the full informed consentform.
**Part i: Information sheet**
**Introduction**: I, Dr. Sheeba Nasrullah Malik, a post graduatestudent in respiratory medicine am doing my study on the topic titled “To compare and determine the effect of probiotic (lactic acid bacilli)supplementation on inflammatory biomarkers during intensive treatment phase ofPulmonary tuberculosis: A prospective studyâ€
I shall give you the necessary information and wouldinvite you to be a part of this research. You do not have to decide todaywhether you will take part or not in the study. You are free to talk to anyoneyou feel comfortable with about the research. If you do not understand some ofthe words or concepts, I shall take time to explain them as you go along andyou are free to ask questions now or later.
**Purpose of the research**: The main purpose of this research is to To compare and determine the effect ofprobiotic (lactic acid bacilli) supplementation on inflammatory biomarkers during intensive treatmentphase of Pulmonary tuberculosis
**Type of research intervention**: Undergo investigations I.e Blood tests like CBC,ESR, CRP
**Participant selection**: All the patients presenting to various departmentsof the hospital and district TB centre who are diagnosed with pulmonary andextra-pulmonary tuberculosis and are under treatment are recruited
**Voluntary participation**: Your participation in the study is entirely yourchoice. The treatment offered toyou will not change under anycircumstances even if you refuse to participate in this study.
**Description of the process**: Informed written consent will be obtained. You areassured that there will not be any untoward event that might follow because ofyour participation in the study. Afterobtaining your consent, 3-5ml ofblood sample will be taken after proper instructions and there might be a milddiscomfort due to venous puncture to investigate for CBC and ESR levels After that based on randomisation, add-onmedication I.e probiotics ( lactic acid bacilli) will be started (probiotics are “non-pathogenic microorganisms that when administered in adequate amounts confer health benefits in the host.â€) andthen, at the end of 2 months, CBC andESR will be repeated for comparision.These would be done free of cost.
Probiotics can lead to mild stomach upset, diarrhoea,flatulence or bloating.
**Benefits**:If you participate in this study, I would be able to detect the improvement ofthe disease due to therapy and probiotics. This might also improve yourtreatment outcome for tuberculosis and prevent further complications of thedisease. Also, all the mentioned investigations, would be done for free due toyour participance in the study
**Reimbursements**: you will not be given any money or gifts to takepart in this study.
**Confidentiality:** Information that we collect from this study will bekept confidential. Information about youthat will be collected duringthe study will be put away and the details will be kept confidential.
**Sharing the results**: The knowledge that we get from doing this researchwill be shared with you before it is made widely available to the public.Confidential information will be kept.
**Right to refuse or withdraw**:You are free to withdraw your participationat any point of the study.
**Whom to contact**: if you have any question, you may ask now or later,even after the study has started.
If you wish to ask questions later, you may contact:
Investigator: DR. SHEEBA NASRULLAH MALIK
Contact no: 9149916102
**Part ii: Certificate of Consent**
I have read the foregoing information, or it has beenread to me. I have had the opportunity to ask questions about it and anyquestions that I have asked have been answered to my satisfaction. I consentvoluntarily to participate as a participant in this research.
Name of participant\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Signature of participant \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date / /202
If illiterate, a literate witness must sign (ifpossible, this person should be selected by the participant and should have noconnection to the research team). Participants who are illiterate shouldinclude their thumb-print as well.
I have witnessed the accurate reading of the consentform to the potential participant, and the individual has had the opportunityto ask questions. I confirm that the individual has given consent freely.
Name of witness\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Thumb print of participant:
Signature of witness \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date / / 202
**Statement by the researcher/ person taking consent**
I, DR. SHEEBA NASRULLAH MALIK have accurately read outthe information sheet to the potential participant, and to the best of myability made sure that the participant understands that the following will bedone:
**1**.Undergo investigations like CBC and ESR with detailed history and performrelevant examination
**2**.Information obtained will be used in research, and published, keeping theinformation confidential.
I confirm that the participant was given anopportunity to ask questions about the study, and all the questions asked bythe participant have been answered correctly and recorded accordingly. Iconfirm that the individual has not been coerced into giving consent, and theconsent has been given freely and voluntarily.
A copy of this ICF has been provided to theparticipant
Name of researcher/person taking the consent:
Signature of researcher /person taking the Consent ಶà³à²°à²¿à³• ಸಿದà³à²§à²¾à²°à³à²¥ ವೈದà³à²¯à²•à²¿à³•à²¯ ಕಾಲೇಜೠಮತà³à²¤à³ ಸಂಶೋಧನಾ ಕೇಂದà³à²°
ರೋಗಿಯ ಮಾಹಿತಿ ನಮೂನೆ
ಯೋಜನೆಯ ಶೀರà³à²·à²¿à²•à³†: To compareand determine the effect of probiotic (lactic acid bacilli) supplementation oninflammatory biomarkers during intensive treatment phase of Pulmonarytuberculosis : A prospective studyâ€
ಪಿ.ಜಿ.ವಿದà³à²¯à²¾à²°à³à²¥à²¿: Dr. SHEEBA NASRULLAH MALIK
ಗೈಡà³: Dr. B G SAROJA
ಶೋಧನೆಉದà³à²¦à³†à³•à²¶à²µà³†à³•à²¨à³ : To compareand determine the effect of probiotic (lactic acid bacilli) supplementation on inflammatory biomarkersduring intensive treatment phase of Pulmonary tuberculosis: A prospectivestudyâ€
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ರೋಗಿಯಸಹಿ (SIGN):
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• ಹೆಚà³à²šà²¿à²¨à²®à²¾à²¹à²¿à²¤à²¿à²—ಾಗಿ ಕೋರಿಕೆ: ನಾನೠಯಾವà³à²¦à³†à³• ಸಮಯದಲà³à²²à²¿ RESPIRATORY MEDICINE ವಿà²à²¾à²—ದಲà³à²²à²¿ Dr. SHEEBA NASRULLAH MALIK ಅವರೊಂದಿಗೆ ಅಧà³à²¯à²¯à²¨à²¦à²¬à²—à³à²—ೆ ಹೆಚà³à²šà²¿à²¨à²ªà³à²°à²¶à³à²¨à³† ಗಳನà³à²¨à³ ಕೇಳಬಹà³à²¦à³. ಈ ಮಾಹಿತಿಯ ನಕಲೠನನಗೆ ನೀಡಲಾಗà³à²¤à³à²¤à²¦à³†.
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ರೋಗಿಯಸಹಿ (SIGN) :
ಶà³à²°à²¿à³•à²¸à²¿à²¦à³à²§à²¾à²°à³à²¥ ವೈದà³à²¯à²•à²¿à³•à²¯à²•à²¾à²²à³†à³•à²œà³ ಮತà³à²¤à³ ಸಂಶೋಧನಾ ಕೇಂದà³à²°
ಅಗಲಕೋಟೆ, ಬಿಎಚà³à²°à²¸à³à²¤à³†, ತà³à²®à²•à³‚ರà³-572107
ಫà³à²¯à²¾à²•à³ :0816-278867 ದೂರವಾಣಿ :0816-2752110 ಇಮೇಲà³: [SSMC\_tmk@hotmail.com](mailto:SSMC_tmk@hotmail.com)
ಮಾಹಿತಿಯà³à²•à³à²¤ ಸಮà³à²®à²¤à²¿à²¯ ನಮೂನೆ
ಅಧà³à²¯à²¯à²¨à²¦ ಶೀರà³à²·à²¿à²•à³†: To compare and determine the effect of probiotic (lactic acid bacilli)supplementation on inflammatory biomarkers during intensive treatment phase ofPulmonary tuberculosis: A prospective studyâ€
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ಸಂಸà³à²¥à³† ಹೆಸರà³: ಶà³à²°à²¿à³• ಸಿದà³à²§à²¾à²°à³à²¥ ವೈದà³à²¯à²•à²¿à³•à²¯ ಕಾಲೇಜೠಆಸà³à²ªà²¤à³à²°à³† ಮತà³à²¤à³ ಸಂಶೋಧನಾ ಕೇಂದà³à²°
ನಾನೠ/\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_ ಶà³à²°à²¿à³• ಸಿದà³à²§à²¾à²°à³à²¥à²µà³†à³–ದà³à²¯à²•à²¿à³•à²¯ ಕಾಲೇಜà³, ಆಸà³à²ªà²¤à³à²°à³† ಮತà³à²¤à³ ಸಂಶೋಧನಾ ಕೇಂದà³à²°, ತà³à²®à²•à³‚ರà³, ನಡೆಯà³à²¤à³à²¤à²¿à²°à³à²µ : To compareand determine the effect of probiotic (lactic acid bacilli) supplementation oninflammatory biomarkers during intensive treatment phase of Pulmonarytuberculosis: A prospective studyâ€
· ಪಾಲà³à²—ೊಳà³à²³à²²à³ ನನà³à²¨ ಅನà³à²®à²¤à²¿à²¯à²¨à³à²¨à³ ನೀಡà³à²¤à³à²¤à²µà³†.
· ವೈದà³à²¯à²°à³ ನನà³à²¨ ವೈದà³à²¯à²•à²¿à³•à²¯ ಸà³à²¥à²¿à²¤à²¿à²¯à²¨à³à²¨à³ ವಿವರಿಸಿದà³à²¦à²¾à²°à³†.
· ನಾನೠನನಗೆ ನಿರà³à²¦à²¿à²·à³à²Ÿ ಎಂದೠಅಪಾಯಗಳನà³à²¨à³ ಸೇರಿದಂತೆ ಕಾಯಿಲೆಯ ಅಪಾಯಗಳà³, ಮತà³à²¤à³ ಸಂà²à²¾à²µà³à²¯ ಫಲಿತಾಂಶಗಳ ಅರà³à²¥.
· ವೈದà³à²¯à²°à³ ಇತರ ಸೂಕà³à²¤ ಚಿಕಿತà³à²¸à³† ಆಯà³à²•à³† ಗಳನà³à²¨à³ ಮತà³à²¤à³ ಅವà³à²—ಳ ಅಪಾಯಗಳನà³à²¨à³ ವಿವರಿಸà³à²¤à³à²¤à²¾à²¨à³†.
· ವೈದà³à²¯à²°à³ ನನà³à²¨ ಮà³à²¨à³à²¨à²°à²¿à²µà³ ಮತà³à²¤à³ ಚಿಕಿತà³à²¸à³† ಇಲà³à²²à²¦à²¿à²°à³à²µ ಅಪಾಯಗಳನà³à²¨à³ ವಿವರಿಸà³à²¤à³à²¤à²¾à²¨à³†.
· ನನಗೆ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳಲೠಮತà³à²¤à³ ನನà³à²¨ ಪರಿಸà³à²¥à²¿à²¤à²¿,ಚಿಕಿತà³à²¸à³† ಮತà³à²¤à³ ಅದರ ಅಪಾಯಗಳಬಗà³à²—ೆ ವೈದà³à²¯à²°à²¨à³à²¨à³ ಕಾಳಜಿಮೂಡಿಸಲೠಸಾಧà³à²¯à²µà²¾à²—à³à²¤à³à²¤à²¦à³†.
· ನನà³à²¨ ಪà³à²°à²¶à³à²¨à³† ಗಳೠಮತà³à²¤à³ ಕಾಳಜಿ ಗಳà³à²šà²°à³à²šà²¿à²¸à²²à²¾à²—ಿದೆ ಮತà³à²¤à³ ನನà³à²¨ ತೃಪà³à²¤à²¿à²‰à²¤à³à²¤à²°à²—ಳನà³à²¨à³ ನೀಡಲಾಗಿದೆ.
· ನಾನೠಅಧà³à²¯à²¯à²¨à²¦ ಒಂದೠà²à²¾à²—ವಾಗಿದೆ ಎಂದೠಒಪà³à²ªà³à²¤à³à²¤à²¿à³•à²°.ರೋಗಿಯಹೆಸರೠ\_\_\_\_\_\_\_\_\_\_\_\_\_ ಸಹಿ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ ದಿನಾಂಕ \_\_\_\_\_\_\_\_\_\_\_\_\_\_ ಟೈಮೠ\_\_\_\_\_\_\_\_\_\_\_\_
· ನಿಷà³à²ªà²•à³à²·à²ªà²¾à²¤à²¿à²¸à²¾à²•à³à²·à²¿à²¯à²¹à³†à²¸à²°à²¿ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ ಸಹಿ \_\_\_\_\_
· SRISIDDHARTHA MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER
DEPARTMENT OFRESPIRATORY MEDICINE, ರೋಗಿಯ ಮಾಹಿತಿ ಸಮà³à²®à²¤à²¿ ಪತà³à²° ಅಧà³à²¯à²¯à²¨ ಶೀರà³à²·à²¿à²•à³†:
To compare and determinethe effect of probiotic (lactic acid bacilli) supplementation on inflammatorybiomarkers during intensive treatment phase of Pulmonary tuberculosis: aprospective studyâ€
ಹೆಸರೠ: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ವಯಸà³à²¸à³ : \_\_\_\_\_\_\_\_
ಲಿಂಗ : \_\_\_\_\_\_\_\_\_
ಕಂ. ಸಂ
ವಿವರಗಳà³
ಪà³à²°à²¯à³‹à²—ಾರà³à²¥à²¿à²¯ ಸಹಿ
1. ಈ ಮೂಲಕ ನಾನೠಧೃಢೀಕರಿಸà³à²µà³à²¦à³‡à²¨à³†à²‚ದರೆ, ಮೇಲೆಕಾಣಿಸಿರà³à²µ ಅಧà³à²¯à²¯à²¨à²¦ ಮಾಹಿತಿ ಪತà³à²°à²µà²¨à³à²¨à³ ನಾನೠಓದಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಅರà³à²¥à²®à²¾à²¡à²¿à²•à³Šà²‚ಡಿದà³à²¦à³‡à²¨à³† ಮತà³à²¤à³ ಪà³à²°à²¶à³à²¨à³†à²—ಳನà³à²¨à³ ಕೇಳà³à²µ ಅವಕಾಶ ನನಗೆ ದೊರಕಿದೆ.
ಅಧà³à²¯à²¯à²¨ ವೈದà³à²¯à²°à³ ಅಥವಾ ಅಧà³à²¯à²¯à²¨à²¦ ಸಿಬà³à²¬à²‚ದಿವರà³à²—ದ ಸದಸà³à²¯à²°à³ ಈ ಮಾಹಿತಿಯನà³à²¨à³ ವಿವರಿಸಿದà³à²¦à²¾à²°à³† ಮತà³à²¤à³ ನನà³à²¨à³†à²²à³à²²à²¾à²ªà³à²°à²¶à³à²¨à³†à²—ಳಿಗೆ ನನಗೆ ಸಮಾಧಾನವಾಗà³à²µà²‚ತೆ ಉತà³à²¤à²°à²¿à²¸à²¿à²¦à³à²¦à²¾à²°à³†.
2. ಅಧà³à²¯à²¯à²¨à²¦à²²à³à²²à²¿à²¨ ನನà³à²¨ à²à²¾à²—ವಹಿಸà³à²µà²¿à²•à³†à²¯à³ ನನà³à²¨ ಸà³à²µ-ಇಚà³à²›à³†à²—ೆ ಸೇರಿದ ವಿಷಯ. ಇದರಿಂದ ನಾನೠಯಾವಾಗ ಬೇಕಿದà³à²¦à²°à³‚ ಹೊರಬರಲೠಸà³à²µà²¤à²‚ತà³à²°à²¨à²¿à²¦à³à²¦à³‡à²¨à³†.
ಅದಕà³à²•à²¾à²—ಿ ನಾನೠಯಾವà³à²¦à³‡ ಕಾರಣಕೊ ಡಬೇಕಾಗಿಲà³à²² ಮತà³à²¤à³ ಇದರಂದಾಗಿ ನನà³à²¨ ವೈದà³à²¯à²•à³€à²¯ ಆರೈಕೆ ಮತà³à²¤à³ ಕಾನೂನà³à²¹à²•à³à²•à³à²—ಳಿಗೆ ಬಾಧಕವಾಗà³à²µà³à²¦à²¿à²²à³à²² ಎಂದೠನನಗೆ ತಿಳಿದಿದೆ.
3.ಈ ಅಧà³à²¯à²¯à²¨à²¦à²¿à²‚ದ ಉದà³à²à²µà²¿à²¸à³à²µ ಯಾವà³à²¦à³‡ ವಿವರ ಅಥವಾ ಫಲಿತಾಂಶವನà³à²¨à³ ಕೇವಲ ವೈಜà³à²žà²¾à²¨à²¿à²• ಉದà³à²¦à³‡à²¶ (ಗಳಿಗೆ)ಕà³à²•à²¾à²—ಿ ಉಪಯೋಗಿಸà³à²µà³à²¦à²¾à²¦à²²à³à²²à²¿ ಮಿತಿಹೇರದಿರಲೠನಾನೠಒಪà³à²ªà²¿ ಕೊಂಡಿದà³à²¦à³‡à²¨à³†.
4. ಮೇಲಿನ ಅಧà³à²¯à²¯à²¨à²¦à²²à³à²²à²¿ à²à²¾à²—ವಹಿಸಲೠನಾನೠಒಪà³à²ªà²¿à²•à³Šà²‚ಡಿದà³à²¦à³‡à²¨à³†.
ಪà³à²°à²¯à³‹à²—ಾರà³à²¥à²¿à²¯ ಸಹಿ / ಹೆಬà³à²¬à³†à²Ÿà³à²Ÿà³à²—à³à²°à³à²¤à³ : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ದಿನಾಂಕ : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ಸಾಕà³à²·à²¿à²—ಾರರ ಸಹಿ (ಅನà³à²µà²¯à²¿à²¸à²¿à²¦à²²à³à²²à²¿) : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ದಿನಾಂಕ : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ಸಂಶೋಧಕರ ಸಹಿ : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
ದಿನಾಂಕ : \_\_\_\_
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 78
Newly diagnosed Pulmonary TB patients, aged 18-65 years ( as per WHO diagnostic criteria) Written consent from the patient.
- Patients of Extrapulmonary TB Pregnant women Immunocompromised patients and patients on immunosuppresive agents Patients with comorbidities like cardiovascular diseases (Hypertension, Ischaemic heart diseases, Cardiomyopathies), Diabetes, gastrointestinal disease, liver malfunction, tumor, severe mental or psychological illness, or cognitive impairment The use of probiotic supplementation within the previous 2 months.
- No informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyse impact of probiotic supplementation on inflammatory biomarkers like CRP (C-reactive protein), ESR ( erythrocyte sedimentation rate), TLC( Total leucocyte count), NEU( neutrophil counts) , MPV( mean platelet volume) in intensive treatment phase of Tuberculosis. 2 time points | Baseline and end of 2 months
- Secondary Outcome Measures
Name Time Method To assess role of probiotics in the duration of sputum culture conversion To assess effect of probiotics on gastric side-effects of anti-tuberculosis treatment
Trial Locations
- Locations (1)
Sri Siddhartha Medical College
🇮🇳Tumkur, KARNATAKA, India
Sri Siddhartha Medical College🇮🇳Tumkur, KARNATAKA, IndiaDr Sheeba MalikPrincipal investigator9149916102maliksheeba1@gmail.com