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Can a milk sugar tame IBD symptoms?

NCT ID NCT03847467

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

128 people

The number who actually took part.

Started

Sep 2019

Finished

May 2026

Lead sponsor

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

11 to 25 years

Sex

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

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

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

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