Gut Transit Effect on Enterohepatic Circulation | NCT03501498

Studies
Gut Transit Effect on Enterohepatic Circulation

NCT03501498

Sponsor

University Hospital Plymouth NHS Trust

Status

Completed

Last Update Posted

Sep 30, 2022Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Intestinal Transit

Interventions

Loperamide
Senna

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
221556	Other Identifier	Integrated Research Application System (IRAS)

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2017Actual

Primary Completion Date

May 7, 2018Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 10, 2018

First Submission Date that Met QC Criteria

Apr 10, 2018

First Posted Date

Apr 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2022

Last Update Posted Date

Sep 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
loperamide	Experimental	Slows intestinal transit time	Drug: Loperamide
senna	Experimental	Speeds up intestinal transit time	Drug: Senna

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Loperamide	Drug	Alters intestinal transit time.	loperamide
Senna

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Stool bacterial count	Bacterial count	7 days
1. common stool test	calprotectin	7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Lewis, MD	University Hospital Plymouth NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Derriford Hospital		Plymouth			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008139	Loperamide
D000081226	Sennosides

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D012676	Senna Extract

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.