Using a dietary supplement to improve gut health in young patients with inflammatory bowel diseases
Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
This study is testing if a dietary supplement called 2'-Fucosyllactose can help improve gut health in young people aged 11 to 25 with inflammatory bowel diseases like Crohn's disease and ulcerative colitis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 11 Years to 25 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | adalimumab, infliximab, methotrexate |
| Locations | 3 sites (Hartford, Connecticut and 2 other locations) |
| Trial ID | NCT03847467 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and efficacy of 2'-Fucosyllactose (2'-FL) as a dietary supplement in pediatric and young adult patients aged 11 to 25 with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. Participants who are in stable remission and receiving maintenance anti-TNF therapy will be randomly assigned to receive either 2'-FL at varying doses or a placebo. The primary goal is to assess whether 2'-FL can enhance the abundance of beneficial gut bacteria and butyrate levels, which may contribute to improved gut health.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 11 to 25 diagnosed with Crohn's disease or ulcerative colitis who are in remission and receiving stable anti-TNF therapy.
Not a fit: Patients who are currently receiving corticosteroids or are not in remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to enhance gut health and potentially improve the management of IBD in young patients.
How similar studies have performed: While the specific use of 2'-FL in IBD is novel, similar dietary interventions have shown promise in enhancing gut microbiota and improving outcomes in other gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 11 - 25 4. Diagnosed with Crohns Disease or Ulcerative Colitis 5. Disease is in remission * Adult CD (age 18-25): CDAI score \< 150 * Pediatric CD (age 11-17): wPCDAI \< 12.5 * Adult UC (age 18-25): Modified Mayo sub-scores: stool frequency sub-score=0, rectal bleeding sub-score=0 * Pediatric UC (age 11-17): PUCAI score \< 10 6. Not receiving corticosteroids 7. Receiving a stable anti-TNF maintenance dose of adalimumab, infliximab, or the biosimilar infliximab-dyyb for 12 weeks prior to enrollment. A stable infliximab or infliximab-dyyb dose may range from 5 mg/kg every 8 weeks to 10 mg/kg every 4 weeks. A stable adalimumab dose may range from 20 mg every 2 weeks to 40 mg every 7 days. While therapeutic drug monitoring will not be required for inclusion, all drug and anti-drug antibody levels obtained for clinical indications within six months prior to enrollment, and from the screening visit through week 20, will be recorded. 8. If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment. 9. Agreement to not make any major dietary changes throughout study duration. This would include changing usual diet to a vegan diet, Specific Carbohydrate Diet (SCD), or exclusive enteral nutrition (EEN) diet. 10. We will include CD patients who have had one ileo-colic resection, as long as the resection did not include more of the colon than the cecum and ascending colon. CD patients may be enrolled if at least six months post-surgery. Exclusion Criteria: 1. Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator. 2. Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics 3. Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary 4. Treatment with another investigational drug or other intervention within 4 weeks 5. Treatment with other biologic medication for IBD within prior 12 weeks 6. Problem with lactose breakdown 7. Currently pregnant or breast feeding 8. We will exclude CD patients with more than one IBD related surgery, or those with a sub-total colectomy. We will exclude UC patients with colectomy or IBD related surgery. 9. We will not allow concomitant use of anti-diarrheal medications.
Where this trial is running
Hartford, Connecticut and 2 other locations
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Ramona Bezold, BSN
- Email: Ramona.Bezold@cchmc.org
- Phone: 1-(513)-636-1412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.