Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome with diarrhoea (IBS-D); Digestive System; Irritable bowel syndrome with diarrhoea

• Registration Number: ISRCTN17149988
• Lead Sponsor: Enteromed Ltd

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32000822/ (added 19/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35760493/ (added 28/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-15
• Study Completion: 2021-10-31
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 439

Inclusion Criteria

Current inclusion criteria as of 04/04/2019:
1. Written informed consent
2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
3. Aged 16-75
4. Considered suitable to take part in the study by the consenting doctor/nurse
5. Diary completed on at least 11 of 14 days (=75%) during the screening period

Previous inclusion criteria from 17/10/2018 to 04/04/2019:
1. Written informed consent
2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
3. Aged 18-75
4. Considered suitable to take part in the study by the consenting doctor/nurse
5. Diary completed on at least 11 of 14 days (=75%) during the screening period

Original inclusion criteria:
1. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
2. Negative calprotectin test or adequate exclusion of Inflammatory Bowel Disease (IBD)
3. Aged 18+
4. Considered suitable to take part in the study by the consenting physician

Exclusion Criteria

Current exclusion criteria as of 07/01/2020:
1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
2. Average abdominal pain <2.5 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
3. Previously diagnosed coeliac disease
4. Previously diagnosed Inflammatory Bowel Disease
5. Previous bowel cancer or bowel resection
6. Other previously known gastrointestinal disorder contributing to the diarrhoea
7. Unexplained weight loss
8. Unexplained rectal bleeding
9. Previous use of Enterosgel®
10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
12. Participation in any research where treatment is provided, or was provided in the last three months
13. Pregnancy

Previous exclusion criteria from 04/04/2019 to 07/01/2020:
1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
3. Previously diagnosed coeliac disease
4. Previously diagnosed Inflammatory Bowel Disease
5. Previous bowel cancer or bowel resection
6. Other previously known gastrointestinal disorder contributing to the diarrhoea
7. Unexplained weight loss
8. Unexplained rectal bleeding
9. Previous use of Enterosgel®
10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
12. Participation in any research where treatment is provided, or was provided in the last three months
13. Pregnancy

Previous exclusion criteria from 17/10/2018 to 04/04/2019:
1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
3. IBS-SSS=400
4. Previously diagnosed coeliac disease
5. Previously diagnosed Inflammatory Bowel Disease
6. Previous bowel cancer or bowel resection
7. Other previously known gastrointestinal disorder contributing to the diarrhoea
8. Unexplained weight loss
9. Unexplained rectal bleeding
10. Previous use of Enterosgel®
11. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
12. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
13. Participation in any research where treatment is provided, or was provided in the last three months
14. Pregnancy

Original exclusion criteria:
1. Loose stools (BSFS 6 or 7) on less than 3 days during the last 14 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified