Evaluation of probiotic Akkermansia Muciniphila strain in patients with IBS.

Phase 3

• Conditions: Health Condition 1: K588- Other irritable bowel syndrome

• Registration Number: CTRI/2024/03/064023
• Lead Sponsor: Vidya Herbs Pvt LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patient should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least a day or week in the last 3 month associated with two or more of the following:(Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)].

2.Patients willing to provide written informed consent and comply to protocol requirements.

Exclusion Criteria

1.Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding.

2.Known inflammatory bowel disease or celiac disease patients.

3.Immuno-compromised patients

4.Pregnancy or wishing to become pregnant during the study.

5.End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases greater than 3.5x above normal)

6.The use of other probiotic products or antibiotics over the previous 6 months

7.Participation in other clinical trials

8.The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global response to treatment for the target lesion based on IBS severity (IBS-SSS), <br/ ><br>The maximum achievable score was 500 and cases were indicated by scores of <br/ ><br>Mild: - 75 to 175 <br/ ><br>Moderate: - 175 to 300 <br/ ><br>Severe: - Greater than 300Timepoint: •Baseline (Day 01) <br/ ><br>•Visit 02 (Day 45): <br/ ><br>Interim visit <br/ ><br>•Visit 03 (Day 90): End of Study

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Probiotic–Akkermansia Muciniphila Strain in patients with irritable bowel syndrome.Timepoint: •Baseline (Day 01) <br/ ><br>•Visit 02 (Day 45): <br/ ><br>Interim visit <br/ ><br>•Visit 03 (Day 90): End of Study