The Endocrine Colon in Humans

University of Copenhagen

Status: Unknown

Conditions: Healthy

Treatments: Other: Lactulose; Other: Placebo (water); Other: Picoprep

Study type: Interventional

Funder types: Other

Identifiers

NCT04159181

CBC-COLON-18

Details and patient eligibility

About

This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy young men (self-reported)
• BMI between 18,5-24,9 kg/m^2

Exclusion criteria

• 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
• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

10 participants in 3 patient groups

Day A

Experimental group

Description:

After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).

Treatment:

Other: Lactulose

Day B

Experimental group

Description:

After an overnight fast participants will drink 200mL of water

Treatment:

Other: Placebo (water)

Day C

Experimental group

Description:

After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water).

Treatment:

Other: Picoprep

Other: Lactulose