Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy

NCT04141826 | Completed DMC

• 1 other identifier: 1-10-72-111-19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.

Conditions

Nutritional Deficiency; Ileostomy; Functional Disturbance; Short Bowel Syndrome; Absorption; Disorder, Protein

Outcome Measures

Primary Outcomes (1)

• 24-hour fecal wet weight

  Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period

  4 weeks

Secondary Outcomes (15)

• Diuresis

  4 weeks

• Natriuresis

  4 weeks

• Amino acid absorption

  6 hours

• Gastric and small bowel emptying

  6 hours

• GLP1 and GLP2

  6 hours

Study Arms (3)

Hydrolysed whey

EXPERIMENTAL

Hydrolysed whey

Dietary Supplement: Hydrolysed whey

Intact whey

ACTIVE COMPARATOR

Intact whey

Dietary Supplement: Intact whey

Caseinate

PLACEBO COMPARATOR

Caseinate

Dietary Supplement: Caseinate

Interventions

Hydrolysed whey DIETARY_SUPPLEMENT

500 mL solution of 25 gram hydrolysed whey per day during 4 weeks

Hydrolysed whey

Intact whey DIETARY_SUPPLEMENT

500 mL solution of 25 gram intact whey per day during 4 weeks

Intact whey

Caseinate DIETARY_SUPPLEMENT

500 mL solution of 25 gram casein ate per day during 4 weeks

Caseinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years old), male or female patients with an ileostomy and intestinal insufficiency
• Episodical or chronic sodium depletion defined by two urine samples with sodium levels ≤ 20 mmol/L, sampled with at least 28 days apart
• Six months or more after most recent bowel surgery
• If inflammatory bowel disease, no clinical signs of activity (any treatment allowed except systemic steroids \> 10 mg/day)

You may not qualify if:

• Parenteral nutrition or intravenous fluid support ≥ 4000 mL/month
• Ongoing infection (C-reactive protein above 8 mg/L or core temperature \>38.0°C)
• Self-reported intolerance to dairy products, including lactose intolerance
• Inability to understand Danish or the trial procedures
• Known or anticipated pregnancy
• Known severe renal insufficiency (eGFR \< 20 mL/min)
• Known diabetes mellitus (HbA1c ≥ 48 mmol/mol (6.5%))
• Pacemaker, cochlear implants, or other electrical implants excludes the participants from BIA-measurements and measurements of GITT with 3D-Transit capsules, but not the remaining investigations
• Known intestinal stenosis or parastomal hernia excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
• Abdominal diameter \> 140 cm, or planned MR scan four weeks following participation excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations

Sponsors & Collaborators

• Christian Hvas: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Rud CL, Hvistendahl MK, Langdahl B, Kraglund F, Baunwall SMD, Lal S, Jeppesen PB, Hvas CL. Protein-based oral rehydration solutions for patients with an ileostomy: A randomised, double-blinded crossover study. Clin Nutr. 2024 Jul;43(7):1747-1758. doi: 10.1016/j.clnu.2024.05.038. Epub 2024 May 28.

  PMID: 38850996 DERIVED

MeSH Terms

Conditions

Malnutrition; Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian L Hvas, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Production in separate facility, randomisation key kept by third party
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, associate professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 28, 2019
• Study Start: January 27, 2020
• Primary Completion: November 1, 2022
• Study Completion: July 13, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: upon request, after publication
• Access Criteria: contact to PI

Locations

DK (1)