A study to evaluate the efficacy and safety of probiotics in a bowel condition associated with Diarrhoea, constipation and abdominal pain.
- Conditions
- Health Condition 1: K582- Mixed irritable bowel syndrome
- Registration Number
- CTRI/2021/04/032513
- Lead Sponsor
- Apollo Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female subjects ranging in age from 18 to 50 years.
2. Fulfilling Rome IV diagnostic criteria for functional IBS-25 Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
3. Having GSRS-IBS pain score (question 1 and 2) between 7 and 12.
4. Willingness to follow the protocol requirement as evidenced by written, informed consent.
5. Willingness to complete subject diaries and respond to study questionnaires.
6. Except study treatment and rescue medicine, if required, agree not to use any other (including vitamins and minerals) medication during the course of the study.
7. Agree not to use any yogurt during the course of this study.
8. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
9. Subjectâ??s assurance that they have not taken antibiotics or other products whose primary site of action is in the gastro intestinal tract (GIT) for a period up to 1 month prior to the start of the study.
1. Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
2. Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
3. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) complete blood count (CBC), Liver Function test (LFT), C-reactive protein (CRP).
4. History or presence of significant alcoholism or product abuse in the past one year.
5. Participation in a clinical study during the preceding 75 days.
6. History of malignancy or other serious disease.
7. Any contraindication to blood sampling.
8. Smoking or consumption of tobacco products.
9. Female subjects on pregnancy and lactating women.
10. Use of any antibiotics (e.g. neomycin, rifaximin) within 1 month of screening,
11. Daily use of laxative within one month of screening/current usage, or usage from the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of oral probiotic Sporlac® against the placebo in IBS, in terms of: <br/ ><br>- The change in severity of symptoms related to abdominal pain, bloating, constipation, diarrhoea, and satiety on the the gastrointestinal symptom rating scale-IBS version (GSRS-IBS)21 at 30, 60, and 75 days compared with baseline. <br/ ><br>- Number of responders to treatment defined by the Subjectâ??s Global Assessment (SGA) of Relief 22 at 30 and 60 days. <br/ ><br>Timepoint: 30 days, 60 days and 75 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess overall health and wellbeing of subjects measured on the SF-8 Health Survey (4-week Recall) questionnaire 23 at 30, 60, and 75 days compared to baseline.Timepoint: 30 days, 60 days and 75 days