Clinical trial on Irritable Bowel Syndrome having constipation.

Phase 3

Completed

• Conditions: Health Condition 1: K528- Other specified noninfective gastroenteritis and colitis

• Registration Number: CTRI/2020/05/024972
• Lead Sponsor: Zeushygia Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male or female subjects ranging in age from 18 to 65 years (both inclusive) diagnosed as having gastro intestinal disorders by the Investigator.

2.Fulfilling Rome IV Diagnostic Criteria for Functional IBS. Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

a)Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:

i.Related to defecation

ii.Onset associated with a change in frequency of stool

iii.Onset associated with a change in form (appearance) of stool

b)Recurrent feeling of bloating or visible distension at least 1 day/week in the last 3 months

c)Disordered bowel habits are typically present (constipation, diarrhoea or a mix of constipation and diarrhoea)

3.Willingness to follow the protocol requirement as evidenced by written, informed consent.

4.Willingness to complete subject diaries and study questionnaires.

5.Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.

6.Agree not to use any yogurt and be on stable fiber therapy during the course of this study.

7.Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range

8.Subjectâ??s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study.

9.Normal colonoscopy/sigmoidoscopy

10.Able to refrain from use of medications known to treat or associated with constipation symptoms

Exclusion Criteria

1.Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorders

2.Diarrhoea-predominant or alternating (diarrhoea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS

3.Any clinically significant medical history, medical finding or an ongoing medical or psychiatric and /or prior abdominal or GI surgical 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

4.Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding.

5.Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry, urinalysis.

6.History or presence of significant alcoholism or drug abuse in the past one year.

7.Participation in a clinical study during the preceding 90 days.

8.History of malignancy or other serious disease.

9.Any contraindication to blood sampling.

10.Smoking or Consumption of tobacco products.

11.Blood or blood products donated in past 30 days prior to study supplement administration.

12.Female subjects on pregnancy and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients with weekly average of 3 or more spontaneous complete bowel movements (SCBM) <br/ ><br>â?¢Global Improvement in signs and symptoms of IBS (IBS severity score) <br/ ><br>Time Points: At Baseline, 1st day to -7th day; 7th day-14th day; 14th day-21st day; 21st day-28th day and at the end of follow up after 4th week <br/ ><br>â?¢Inflammatory Markers: ESR, IL6, TNF-alpha & NF Kappa B. <br/ ><br>â?¢Gut microbial analysis (Changes in gut micro flora from day 0 and day 30) <br/ ><br>Timepoint: Day 0,Day 14,Day 21 and Day 30

Secondary Outcome Measures

Name	Time	Method
1 Evaluating the Stress levels in subjects by standard stress questionnaire <br/ ><br>2 Proportion of subjects who achieve improvement in Constipation; abdominal pain/discomfort, bowel habits and bloating <br/ ><br>Timepoint: Day 0,Day 14,Day 21 and Day 30