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Evaluation of Probiotic Bacillus Subtilis Strain in Patients with IBS.

Phase 3
Conditions
Health Condition 1: K588- Other irritable bowel syndrome
Registration Number
CTRI/2024/03/064089
Lead Sponsor
Vidya Herbs Pvt LTD
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day or week in the last 3 months) 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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