Intestinal TransitNCT03501498
Gut Transit Effect on Enterohepatic Circulation
A study testing Loperamide and Senna in people with Intestinal Transit, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
A study to determine the influence of changing intestinal transit time of the enterohepatic recirculation of bile acids. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Transit
- What is being tested?
- Loperamide and Senna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2017to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Healthy volunteers between the ages of 18 and 65
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds
A study to determine the influence of changing intestinal transit time of the enterohepatic recirculation of bile acids.
Read the 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
- Being tested
- Loperamide, Senna
- Keywords
- Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoperamideDrug
Alters intestinal transit time.
SennaDrug
Alters intestinal transit time.
| Study group | Role | What they receive |
|---|---|---|
| loperamide | Experimental | Slows intestinal transit time Receives: Drug: Loperamide |
| senna | Experimental | Speeds up intestinal transit time Receives: Drug: Senna |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intestinal transit on faecal bile acids
Change in bile acid pool and activity from baseline with each intervention
Measured: 7 days
Secondary outcomes (5)
Stool bacterial count
Bacterial count
Measured: 7 days
1. common stool test
calprotectin
Measured: 7 days
2. common stool test
elastase
Measured: 7 days
3. common stool test
lactoferrin
Measured: 7 days
Volatile Organic Compounds
VOC estimation in urine
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start10 Apr 2017
- Primary completion7 May 2018
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal TransitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Lewis, MD, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501498
- Sponsor's protocol ID
- 16/P/138
- Other IDs
- 221556
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds
- ClinicalTrials.gov ID
- NCT03501498
- Acronym / sponsor ID
- 16/P/138
- Conditions
- Intestinal Transit
- Keywords
- Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| loperamide | Experimental | Drug: LoperamideSlows intestinal transit time |
| senna | Experimental | Drug: SennaSpeeds up intestinal transit time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Healthy volunteers between the ages of 18 and 65
Key exclusion criteria (11 listed)
- Unable to consent
- Pregnant or lactating
- Known diarrhoeal disorder
- Known constipation.
- Any gastrointestinal disease or previous gastric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoperamideAlters intestinal transit time. | Drug | loperamide |
| SennaAlters intestinal transit time. | Drug | senna |
Primary outcome
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
5 secondary outcomes
Stool bacterial count
Time frame: 7 days
1. common stool test
Time frame: 7 days
2. common stool test
Time frame: 7 days
3. common stool test
Time frame: 7 days
Volatile Organic Compounds
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lewis, MD principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loperamide and Senna in people with Intestinal Transit, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of intestinal transit on faecal bile acids (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.