ACTIVE_NOT_RECRUITING

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.

Official Title

An Open-label, Single Center Investigator Sponsored Study Assessing the Effect of Tenapanor on Metagenomic and Metabolomic Markers in Patients With Irritable Bowel Syndrome With Constipation

Quick Facts

Study Start:2024-02-06

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05995899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ages 18-75 years old 2. BMI \>18.5 and \<35 kg/m2 3. Rome IV criteria for IBS-C for at least 6 months 4. Compliant with baseline stool submission prior to initiation of medication 5. Ability to follow verbal and written instructions 6. Ability to record daily bowel habits, including frequency, stool consistency (BSFS), and symptom severity 7. Willingness to avoid major dietary changes and use of probiotics during the study period 8. Informed consent form signed by the subjects	1. History of loose stools 2. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M) 3. Non-compliance with baseline stool submission 4. Previous use of tenapanor 5. GI motility obstruction or GI tract structural abnormality 6. Current use of prescribed or illicit opioids 7. History of pelvic floor dysfunction 8. Need for manual maneuvers in order to achieve a BM 9. History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study 10. History of high-dose stimulative or cathartic laxative abuse as judged by investigator team 11. Severe IBS-C as judged by the investigator 12. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study 13. Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis 14. BMI of \<18.5 or \>35 kg/m2 15. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation 16. Absence of contraception in females of childbearing potential 17. History of allergic reaction to tenapanor 18. Administration of other FDA-approved agents for the treatment of IBS-C within 1 month prior to Screening Visit: * Linaclotide * Lubiprostone * Plecanatide 19. If treated with any of the following medications, dosing (or approximate frequency of 'as needed' use) must be stable for at least 30 days prior to Screening Visit and the subject must agree to maintain the same dose (or approximate frequency of 'as needed' use) or a decreased dose of medication throughout the study: * Probiotics * Bulk laxatives, fiber, and stool softeners 20. Exclusion of colonic inertia with symptoms of \< 1 BM per 2 weeks 21. Subjects anticipating surgical intervention during the study 22. Known history of diabetes (type 1 or 2) 23. Subjects with recent antibiotic use (last 3 months) or anticipated antibiotic use during the study period 24. History of inflammatory bowel disease 25. Supine SBP \> 160 mm Hg and/or supine DBP \> 95 mm Hg (mean of two consecutive readings) 26. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit 27. History of swallowing disorders 28. History of gastric bypass or any other gastric surgery 29. History of small bowel resection (except if related to appendectomy) 30. History of gastric or duodenal ulcer 31. History of gastroparesis 32. History of abdominal radiation treatment 33. History of pancreatitis 34. History of intestinal stricture (e.g., Crohn's disease) 35. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions 36. History of malabsorption 37. History of hepatitis B or C 38. History of human immunodeficiency virus 39. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer) 40. Any other clinically significant disease interfering with the assessments of tenapanor, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 41. HbA1c \> 8.5% (\> 69 mmol/mol)

Inclusion Criteria

Exclusion Criteria

1. Ages 18-75 years old
2. BMI \>18.5 and \<35 kg/m2
3. Rome IV criteria for IBS-C for at least 6 months
4. Compliant with baseline stool submission prior to initiation of medication
5. Ability to follow verbal and written instructions
6. Ability to record daily bowel habits, including frequency, stool consistency (BSFS), and symptom severity
7. Willingness to avoid major dietary changes and use of probiotics during the study period
8. Informed consent form signed by the subjects

1. History of loose stools
2. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
3. Non-compliance with baseline stool submission
4. Previous use of tenapanor
5. GI motility obstruction or GI tract structural abnormality
6. Current use of prescribed or illicit opioids
7. History of pelvic floor dysfunction
8. Need for manual maneuvers in order to achieve a BM
9. History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study
10. History of high-dose stimulative or cathartic laxative abuse as judged by investigator team
11. Severe IBS-C as judged by the investigator
12. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
13. Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis
14. BMI of \<18.5 or \>35 kg/m2
15. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
16. Absence of contraception in females of childbearing potential
17. History of allergic reaction to tenapanor
18. Administration of other FDA-approved agents for the treatment of IBS-C within 1 month prior to Screening Visit:
* Linaclotide
* Lubiprostone
* Plecanatide
19. If treated with any of the following medications, dosing (or approximate frequency of 'as needed' use) must be stable for at least 30 days prior to Screening Visit and the subject must agree to maintain the same dose (or approximate frequency of 'as needed' use) or a decreased dose of medication throughout the study:
* Probiotics
* Bulk laxatives, fiber, and stool softeners
20. Exclusion of colonic inertia with symptoms of \< 1 BM per 2 weeks
21. Subjects anticipating surgical intervention during the study
22. Known history of diabetes (type 1 or 2)
23. Subjects with recent antibiotic use (last 3 months) or anticipated antibiotic use during the study period
24. History of inflammatory bowel disease
25. Supine SBP \> 160 mm Hg and/or supine DBP \> 95 mm Hg (mean of two consecutive readings)
26. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
27. History of swallowing disorders
28. History of gastric bypass or any other gastric surgery
29. History of small bowel resection (except if related to appendectomy)
30. History of gastric or duodenal ulcer
31. History of gastroparesis
32. History of abdominal radiation treatment
33. History of pancreatitis
34. History of intestinal stricture (e.g., Crohn's disease)
35. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
36. History of malabsorption
37. History of hepatitis B or C
38. History of human immunodeficiency virus
39. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
40. Any other clinically significant disease interfering with the assessments of tenapanor, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
41. HbA1c \> 8.5% (\> 69 mmol/mol)

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Kyle Staller, MD, MPH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-06

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-02-06

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

IBS
IBS - Irritable Bowel Syndrome