The effect of a dairy protein hydrolysate on gut health in an inflammatory bowel disease population
| ISRCTN | ISRCTN64064335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64064335 |
| Sponsor | Food for Health Ireland |
| Funder | Enterprise Ireland |
- Submission date
- 11/08/2026
- Registration date
- 21/09/2026
- Last edited
- 11/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Inflammatory bowel disease (IBD) is characterised by chronic gastrointestinal symptoms (bloating, constipation, blood in stool), which are caused by inflammation in the gut and an imbalance in the gut microbiome (bacteria in the gut). IBD affects many people worldwide and while the disease can be managed through medication, there is no absolute cure. Dietary approaches are important to help ease symptoms in IBD patients. Certain dairy supplements, such as dairy protein derivatives (e.g., casein hydrolysate) may help to improve symptoms in IBD patients. This study aims to understand how supplementation of a casein hydrolysate can potentially improve gut health in an IBD cohort.
Who can participate?
Patients aged over 18 years with IBD in remission (non-active disease)
What does the study involve?
Participants will be randomly assigned to either the intervention group (casein hydrolysate) or the control group (maltodextrin) and will consume 4 g/d of either the casein hydrolysate or the control, for 6 weeks. Participants will come into the St Vincent's University Hospital Gastroenterology Research Unit for two study visits - one at week 0 (baseline) and one at week 6 (post-intervention). During these study visits a range of biological (bloods, faecal) and non-biological (weight, height, quality of life questionnaires) data will be collected.
What are the possible benefits and risks of participating?
There are no direct benefits of participating, although patients will be contributing to important IBD research. There are minimal risks of participating, although it is possible that the casein supplement or maltodextrin supplement may cause gastrointestinal discomfort among IBD patients (certain foods can trigger symptoms in certain people). Participants will be monitored during the study through email and phone calls to assess this, and they are free to drop-out at any time if they wish.
Where is the study run from?
St Vincent's University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
February 2022 to November 2022
Who is funding the study?
Food for Health Ireland, funded by Enterprise Ireland
Who is the main contact?
1. Prof. Glen Doherty, glen.doherty@ucd.ie
2. Dr Cliona Ni Chonnachain, cliona.nichonnachain@ucd.ie
Contact information
Principal investigator, Scientific, Public
University College Dublin, School of Medicine, St Vincent's Hospital, Elm Park, Dublin 4
Dublin
D04 V1W8
Ireland
 ORCID ID |
0000-0003-4384-5049 |
|---|---|
| Phone | +353 (01)2214711 |
| glen.doherty@ucd.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Basic science, Supportive care |
| Participant information sheet | 50073_PIS.pdf |
| Scientific title | The effects of casein hydrolysate supplementation on the gut microbiome and gastrointestinal health in an ulcerative colitis cohort: a randomised controlled pilot study |
| Study objectives | To determine the effects of dietary supplementation with a casein hydrolysate (UL-2-132) on parameters of the gut microbiota and quality of life in a UC cohort. |
| Ethics approval(s) |
Approved 15/01/2021, Research Ethics Committee, St Vincent's University Hospital (Research Ethics Department, Education & Research Centre, St. Vincent’s University Hospital, Elm Park, Dublin 4, Dublin, D04T6F4, Ireland; +353 (01) 221 4000; svhgethics@ucd.ie), ref: RS20-065 |
| Health condition(s) or problem(s) studied | Ulcerative colitis |
| Intervention | A random number generator was used for randomisation. Participants meeting inclusion criteria were randomly assigned to the intervention group (casein hydrolysate UL-2-132) or control group (maltodextrin) on a 1:1 ratio, determined by a random number generator. Intervention arm: 4 g/day of a casein hydrolysate for 6 weeks Control arm: 4 g/day of a maltodextrin control for 6 weeks |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 25/11/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Ulcerative colitis (UC) patients in remission (faecal calprotectin <100 ug/g) 2. >18 years of age |
| Key exclusion criteria | 1. <18 years old 2. Escalation of medical therapy within 3 months prior to the study 3. Inability to provide written informed consent 4. Pregnant or breastfeeding women 5. Dairy allergy 6. Significant comorbid physical or mental health conditions 7. Recent antibiotic or probiotic use (within 3 weeks) 8. Recent or planned exclusion diet or major dietary modification (within 3 months) |
| Date of first enrolment | 22/02/2022 |
| Date of final enrolment | 10/10/2022 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/08/2026 | No | Yes |
Additional files
- 50073_PIS.pdf
- Participant information sheet
Editorial Notes
11/08/2026: Study's existence confirmed by the Research Ethics Committee, St Vincent's University Hospital.
