Gut Transit Effect on Enterohepatic Circulation

NCT03501498 | Completed

• 2 other identifiers: 16/P/138221556
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

A study to determine the influence of changing intestinal transit time of the enterohepatic recirculation of bile acids.

Conditions

Intestinal Transit

Keywords

Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds

Outcome Measures

Primary Outcomes (1)

• The effect of intestinal transit on faecal bile acids

  Change in bile acid pool and activity from baseline with each intervention

  7 days

Secondary Outcomes (5)

• Stool bacterial count

  7 days

• 1. common stool test

  7 days

• 2. common stool test

  7 days

• 3. common stool test

  7 days

• Volatile Organic Compounds

  5 days

Study Arms (2)

loperamide

EXPERIMENTAL

Slows intestinal transit time

Drug: Loperamide

senna

EXPERIMENTAL

Speeds up intestinal transit time

Drug: Senna

Interventions

Loperamide DRUG

Alters intestinal transit time.

loperamide

Senna DRUG

Alters intestinal transit time.

senna

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers between the ages of 18 and 65

You may not qualify if:

• Unable to consent
• Pregnant or lactating
• Known diarrhoeal disorder
• Known constipation.
• Any gastrointestinal disease or previous gastric surgery
• An episode of gastroenteritis within the last month
• Taking any acid suppressing medication
• Any significant medical condition (e.g. diabetes, renal disease)
• Any antibiotic intake within the last one-month
• Any drug with known effects on GI motility
• Known allergy or intolerance to senna or loperamide

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Derriford Hospital

Plymouth, United Kingdom

Location

MeSH Terms

Interventions

Loperamide; Sennosides

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Stephen Lewis, MD

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised cross-over study. Volunteers will be assessed at baseline, then after either taking loperamide or senna at the maximally tolerated dose for 2 days prior to the 'assessment period' then during the assessment period (5-7 days). After a washout period of at least 21 days, volunteers will then repeat the same assessments but cross over to take the second drug either loperamide or senna.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: April 10, 2017
• Primary Completion: May 7, 2018
• Study Completion: March 1, 2022
• Last Updated: September 30, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)