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Completed

NCT Number: NCT03501498

Gut Transit Effect on Enterohepatic Circulation

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derriford Hospital

Plymouth, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loperamide

Drug

Alters intestinal transit time.

Senna

Drug

Alters intestinal transit time.

Primary outcomes

  1. The effect of intestinal transit on faecal bile acids

    Time frame: 7 days

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

Secondary outcomes

  1. Stool bacterial count

    Time frame: 7 days

    Bacterial count

  2. 1. common stool test

    Time frame: 7 days

    calprotectin

  3. 2. common stool test

    Time frame: 7 days

    elastase

  4. 3. common stool test

    Time frame: 7 days

    lactoferrin

  5. Volatile Organic Compounds

    Time frame: 5 days

    VOC estimation in urine

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Apr 18, 2018
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.