HealthyColonNCT04159181
The Endocrine Colon in Humans
A study testing Lactulose and Picoprep in people with Healthy, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactulose and Picoprep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Jul 2018to 1 Jul 2020
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men (self-reported)
- BMI between 18,5-24,9 kg/m^2
Who cannot join
- Diabetes mellitus (elevated fasting plasma glucose or HbA1c)
- Family history of diabetes mellitus
- Intestinal disease (e.g. inflammatory bowel disease, malabsorption)
- Family history of intestinal diseases
- Previous gastrointestinal surgery
- BMI >25 kg/m^2
Show all 19Show fewer
- Tobacco use
- Alcohol consumption > 14 standard drinks/week
- Drug use
- Kidney, Heart- or Liver disease
- Treatment with prescription drugs that can not be held for 12h
- Constipation
- Accelerated or delayed gastric emptying
- Absence of daily bowel movements
- Vegetarian lifestyle
- > than 3kgs weightloss or weight gain within 3 months
- Haemoglobin concentration < 8,0mmol/L
- Bleeding diathesis
- Latex or bandaid allergies
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University of Copenhagen
Copenhagen, Capital, 2200
Hvidovre University Hospital
Hvidovre, Capital, 2650
About this study
Official title: Investigations of the Endocrine Colon in Healthy Individuals
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
Read the detailed description
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
We aim to determine the contribution of the colon to the fasting and postprandial release of gut peptides such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Young healthy men will be examined on three occasions at a clinical research Facility after an overnight fast. On one occasion the colon will also be emptied using a cathartic (picoprep). On two occasions an oral solution of lactulose will be administered to stimulate fermentation by colonic bacteria.
- Conditions
- Healthy
- Being tested
- Lactulose, Picoprep, Placebo (water)
- Keywords
- Colon, PYYs, GLP-1, Gut peptides, Fermentation, Lactulose, human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseOther
Oral solution lactulose (20g lactulose/200mL water).
PicoprepOther
Cathartic to accomplish an evacuation of the colonic content.
Placebo (water)Other
oral administration of Water (200mL).
| Study group | Role | What they receive |
|---|---|---|
| Day A | Experimental | After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water). Receives: Other: Lactulose |
| Day B | Experimental | After an overnight fast participants will drink 200mL of water Receives: Other: Placebo (water) |
| Day C | Experimental | After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water). Receives: Other: Lactulose; Other: Picoprep |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Secondary outcomes (6)
PYY
Plasma concentrations of peptide YY (PYY)
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Hydrogen breath test
Concentrations of hydrogen in exhaled air
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Ghrelin
Plasma concentrations of ghrelin
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Motilin
Plasma concentrations of motilin
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Neurotensin
Plasma concentrations of Neurotensin
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Glucagon
Plasma concentrations of glucagon
Measured: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start16 Jul 2018
- Primary completion31 Jul 2019
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Healthy men studied on three occasions. Study A and B will be conducted in random order. Day C wil always be conducted as the last study day.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Simon Veedfald, University of Copenhagen
- Investigators
- Jens J Holst, MD, Dr.med., Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159181
- Sponsor's protocol ID
- CBC-COLON-18
- Acronym
- Colon
- Status last verified
- Nov 2019
- First submitted
- 9 Jul 2018
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christiansen CB, Veedfald S, Hartmann B, Gauguin AM, Moller S, Moritz T, Madsbad S, Holst JJ. Colonic Lactulose Fermentation Has No Impact on Glucagon-like Peptide-1 and Peptide-YY Secretion in Healthy Young Men. J Clin Endocrinol Metab. 2022 Jan 1;107(1):77-87. doi: 10.1210/clinem/dgab666.
PubMed 34508600
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of the Endocrine Colon in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04159181
- Acronym / sponsor ID
- Colon / CBC-COLON-18
- Conditions
- Healthy
- Keywords
- Colon, PYYs, GLP-1, Gut peptides, Fermentation, Lactulose, human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 12 Nov 2019 (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.
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
Detailed description
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
We aim to determine the contribution of the colon to the fasting and postprandial release of gut peptides such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Young healthy men will be examined on three occasions at a clinical research Facility after an overnight fast. On one occasion the colon will also be emptied using a cathartic (picoprep). On two occasions an oral solution of lactulose will be administered to stimulate fermentation by colonic bacteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Healthy men studied on three occasions. Study A and B will be conducted in random order. Day C wil always be conducted as the last study day.
| Arm | Type | Receives |
|---|---|---|
| Day A | Experimental | Other: LactuloseAfter an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water). |
| Day B | Experimental | Other: Placebo (water)After an overnight fast participants will drink 200mL of water |
| Day C | Experimental | Other: Lactulose, Other: PicoprepAfter an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young men (self-reported)
- BMI between 18,5-24,9 kg/m^2
Key exclusion criteria (19 listed)
- Diabetes mellitus (elevated fasting plasma glucose or HbA1c)
- Family history of diabetes mellitus
- Intestinal disease (e.g. inflammatory bowel disease, malabsorption)
- Family history of intestinal diseases
- Previous gastrointestinal 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 |
|---|---|---|
| LactuloseOral solution lactulose (20g lactulose/200mL water). | Other | Day A, Day C |
| PicoprepCathartic to accomplish an evacuation of the colonic content. | Other | Day C |
| Placebo (water)oral administration of Water (200mL). | Other | Day B |
Primary outcome
GLP-1
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
6 secondary outcomes
PYY
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Hydrogen breath test
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Ghrelin
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Motilin
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Neurotensin
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Glucagon
Time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Derived from this study: PubMed 34508600Christiansen CB, Veedfald S, Hartmann B, Gauguin AM, Moller S, Moritz T, Madsbad S, Holst JJ. Colonic Lactulose Fermentation Has No Impact on Glucagon-like Peptide-1 and Peptide-YY Secretion in Healthy Young Men. J Clin Endocrinol Metab. 2022 Jan 1;107(1):77-87. doi: 10.1210/clinem/dgab666.
- Individual participant dataSharing planned: Undecided
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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.
Jens J Holst, MD, Dr.med. study director
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose and Picoprep in people with Healthy, run by University of Copenhagen at 2 sites in Denmark.
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 2 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
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?
GLP-1 (time frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159181, which also lists 1 linked publication.
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 12 Nov 2019.