Can a milk sugar tame IBD symptoms?
NCT ID NCT03847467
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing whether a prebiotic supplement called 2'-FL, found in human milk, can safely ease gut symptoms in young people with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. Participants, aged 11 to 25, are in remission and already taking anti-TNF medications. They will receive either 2'-FL or a placebo daily, and researchers will measure changes in gut symptoms and beneficial bacteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 2'-Fucosyllactose (2'-FL), a prebiotic dietary supplement
- What this could lead to
- If effective, 2'-FL could become a simple dietary supplement to help manage IBD symptoms and improve gut health in young patients.
- What could go wrong
- This is an early-phase trial, so results may not be conclusive. The supplement might not improve symptoms or could cause digestive discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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128 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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11 to 25 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Other studies related to the condition(s) this trial covers.
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- Can early symptom relief predict who stays on IBD biologic?
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