Gut Transit Effect on Enterohepatic Circulation

NCT ID: NCT03501498

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2022-03-01

Brief Summary

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

Detailed Description

The digestion of food by human body starts from oral cavity and continues until its excreted as faeces. There are different factors affecting this process. Important factors are movement through the GI Tract, breakdown of food material and absorption by the body to produce energy. The unabsorbed waste material is then excreted by the body.

Different enzymes are produced by human body which are responsible for digestion of food. One important chemical is bile which is produced in the gall bladder. It is important in digestion of fatty foods but affects the movement of food material as well. There are numerous bacteria present in human GI tract especially in mouth and large bowel which also play an important role in process of digestion of food.

Different conditions of health and disease can affect how food moves through the GI tract (known as intestinal transit). It also affects the activity of different digestive enzymes and chemicals in body. The bacterial population in the body is also affected by changes described above. The purpose of this study is to observe how these different processes especially the intestinal transit, bile salts and gut bacteria affect each other. This will help to identify mechanisms responsible for different disorders of human gut like irritable bowel syndrome. The study is part of an effort to identify new and future treatment of these conditions.

Conditions

Intestinal Transit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

loperamide

Slows intestinal transit time

Group Type: EXPERIMENTAL

Loperamide

Intervention Type: DRUG

Alters intestinal transit time.

senna

Speeds up intestinal transit time

Group Type: EXPERIMENTAL

Senna

Intervention Type: DRUG

Alters intestinal transit time.

Interventions

Loperamide

Alters intestinal transit time.

Intervention Type: DRUG

Senna

Alters intestinal transit time.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Healthy volunteers between the ages of 18 and 65

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

Derriford Hospital

Plymouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

221556

Identifier Type: OTHER

Identifier Source: secondary_id

16/P/138

Identifier Type: -

Identifier Source: org_study_id