A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.

Not Applicable

Not yet recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT06687720
• Lead Sponsor: NovoBliss Research Pvt Ltd

Brief Summary

This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.

Detailed Description

A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.

Subjectsshall be instructed to visit the facility for the following scheduled visits:

* Visit 01 \[Within 30 days\]: Screening, Blood Parameter Assessment.

* Visit 02 \[Day 01\]: Enrolment, Evaluations, Treatment Dispensing.

* Visit 03 \[Day 15 (±2 days)\]: Telephonic follow-up.

* Visit 04 \[Day 30 (±2 days)\]: Treatment End, Final Evaluations.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Study Start: 2024-11-30
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. The subject is an adult male or female aged between 18 to 60 years old.

2. Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:

   i. Related to defecation ii. A change in frequency of stool iii. A change in form (appearance) of stool iv. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition

3. The subject is having refrigerator at their home for storage of test treatment.

4. The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.

5. The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.

6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.

7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.

   i. Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).

ii. Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.

Exclusion Criteria

1. The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
2. The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
3. The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
4. The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
5. The subject has a history of alcohol abuse.
6. The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
7. The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
8. The subject has other significant gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease).
9. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.
10. The subject has abnormal baseline Haemoglobin (Hb), Complete Blood Count (CBC), Urine Routine/Microscopy (R/M), or Stool Routine/Microscopy (R/M) results that suggest a different pathology than irritable bowel syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in Albumin/Globulin ratio	Baseline before and 6-8 hours post-dose on Day 01 and Day 30	Evaluate the effect of the test treatment in terms of change in Albumin/Globulin ratio
change in total serum protein	Baseline before and 6-8 hours post-dose on Day 01 and Day 30	Evaluate the effect of the test treatment in terms of change in total serum protein
change in prealbumin levels	Baseline before and 6-8 hours post-dose on Day 01 and Day 30	Evaluate the effect of the test treatment in terms of change in prealbumin levels.
Change in the lifestyle using the Scoring and Gradation	Day 01 (before administration) for baseline, and post-dose on Day 30.	Assessment of the effectiveness of the test treatment in terms of change in the lifestyle using the Scoring and Gradation.; Severely disturbed lifestyle- 76%-100% Marked disturbed lifestyle-51%-75% Moderately disturbed lifestyle -25%-50% Mild disturbed lifestyle\<25
Scoring and Gradation of symptoms of irritable bowel syndrome	Day 01 (before administration) for baseline, and post-dose on Day 30.	Evaluate of the effect of test treatment using Scoring and Gradation of symptoms of irritable bowel syndrome.; Complete remission-76%-100% Marked improvement-51%-75% Mild improvement-25%-50% Unchanged\<25%

Secondary Outcome Measures

Name	Time	Method
Performance of safety laboratory tests including Complete Blood Count (CBC)	on Day 30	Evaluate the safety of test treatment through the performance of safety laboratory tests including Complete Blood Count (CBC)
Performance of safety laboratory tests including Biochemical tests	on Day 30	Evaluate the safety of test treatment through the performance of safety laboratory tests including Biochemical tests
Performance of safety laboratory tests including Urinalysis	on Day 30	Evaluate the safety of test treatment through the performance of safety laboratory tests including Urinalysis
Assessment of the effectiveness of the test treatment in terms of change in CRP levels	on Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).	CRP will be evaluated by Lab Parameters
Assessment of the effectiveness of the test treatment in terms of change in IL-6 levels	On Day 01 (before administration) for baseline, and post-dose on Day 30 (±2 days).	IL-6 will be evaluated by Lab Parameters