Nutritional DeficiencyABSOLYTNCT04141826
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
A study testing Hydrolysed whey, Intact whey and Caseinate in people with Nutritional Deficiency and Ileostomy; Functional Disturbance, run by Christian Hvas at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome
- What is being tested?
- Hydrolysed whey, Intact whey and Caseinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jan 2020to 13 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.
- Conditions
- Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome, Absorption; Disorder, Protein
- Being tested
- Hydrolysed whey, Intact whey, Caseinate
- Medical subject headings
- Malnutrition, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed wheyDietary supplement
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
Intact wheyDietary supplement
500 mL solution of 25 gram intact whey per day during 4 weeks
CaseinateDietary supplement
500 mL solution of 25 gram casein ate per day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysed whey | Experimental | Hydrolysed whey Receives: Dietary Supplement: Hydrolysed whey |
| Intact whey | Active comparator | Intact whey Receives: Dietary Supplement: Intact whey |
| Caseinate | Placebo comparator | Caseinate Receives: Dietary Supplement: Caseinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour fecal wet weight
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
Measured: 4 weeks
Secondary outcomes (15)
Diuresis
24 hour urine volume
Measured: 4 weeks
Natriuresis
24 hour urine sodium excretion
Measured: 4 weeks
Amino acid absorption
Plasma amino acids
Measured: 6 hours
Gastric and small bowel emptying
3D transit evaluation
Measured: 6 hours
GLP1 and GLP2
Intestinal hormones during absorption
Measured: 6 hours
Portosystemic hepatic encephalopathy (PSE) test score, median value
Pen and paper test, score with range
Measured: 4 weeks
Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
Pen and paper test, score with range
Measured: 4 weeks
Continuous reaction time (CRT) index median
Reaction to 150 sound stimuli, read-out as index compared to normal values
Measured: 4 weeks
Physical activity
Telemetric sensor
Measured: 4 weeks
Body weight (kg)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Total body water (L)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Extracellular water (L)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Skeletal muscle mass (kg)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Fat-free mass (kg)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Fat mass (kg)
Bio-impedance analysis (SECA)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start27 Jan 2020
- Primary completion1 Nov 2022
- Study completion13 Jul 2023
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 Nutritional DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Hvas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Hvas, Aarhus University Hospital
- Investigators
- Christian L Hvas, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141826
- Sponsor's protocol ID
- 1-10-72-111-19
- Acronym
- ABSOLYT
- Status last verified
- Mar 2024
- First submitted
- 3 Oct 2019
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data or selections herof will be shared upon specific agreements and with researchers who have legitimate causes, following contact to the PI
Publications
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.
PubMed 38850996
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
- ClinicalTrials.gov ID
- NCT04141826
- Acronym / sponsor ID
- ABSOLYT / 1-10-72-111-19
- Conditions
- Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome, Absorption; Disorder, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Christian HvasUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 28 Oct 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.
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.
Detailed description
Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrolysed whey | Experimental | Dietary Supplement: Hydrolysed wheyHydrolysed whey |
| Intact whey | Active comparator | Dietary Supplement: Intact wheyIntact whey |
| Caseinate | Placebo comparator | Dietary Supplement: CaseinateCaseinate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Hydrolysed whey500 mL solution of 25 gram hydrolysed whey per day during 4 weeks | Dietary supplement | Hydrolysed whey |
| Intact whey500 mL solution of 25 gram intact whey per day during 4 weeks | Dietary supplement | Intact whey |
| Caseinate500 mL solution of 25 gram casein ate per day during 4 weeks | Dietary supplement | Caseinate |
Primary outcome
24-hour fecal wet weight
Time frame: 4 weeks
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
15 secondary outcomes
Diuresis
Time frame: 4 weeks
Natriuresis
Time frame: 4 weeks
Amino acid absorption
Time frame: 6 hours
Gastric and small bowel emptying
Time frame: 6 hours
GLP1 and GLP2
Time frame: 6 hours
Portosystemic hepatic encephalopathy (PSE) test score, median value
Time frame: 4 weeks
Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
Time frame: 4 weeks
Continuous reaction time (CRT) index median
Time frame: 4 weeks
Physical activity
Time frame: 4 weeks
Body weight (kg)
Time frame: 4 weeks
Total body water (L)
Time frame: 4 weeks
Extracellular water (L)
Time frame: 4 weeks
Skeletal muscle mass (kg)
Time frame: 4 weeks
Fat-free mass (kg)
Time frame: 4 weeks
Fat mass (kg)
Time frame: 4 weeks
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 4 Mar 2024.
- Derived from this study: PubMed 38850996Rud 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.
- Individual participant dataSharing planned: Yes. Anonymised data or selections herof will be shared upon specific agreements and with researchers who have legitimate causes, following contact to the PI
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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.
Christian L Hvas, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolysed whey, Intact whey and Caseinate in people with Nutritional Deficiency and Ileostomy; Functional Disturbance, run by Christian Hvas at 1 site 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 4 inclusion and 10 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 4 Mar 2024. 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 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. Some participants in this study may receive a placebo. 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?
24-hour fecal wet weight (time frame: 4 weeks). 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 NCT04141826, 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 4 Mar 2024.