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New treatment option for Inflammatory Bowel Diseases
Official title Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy
ClinicalTrials.gov ID: NCT03847467
What this study is testing
What is 2'-Fucosyllactose?
2'-Fucosyllactose is an investigational medicine, given as an once-daily, being studied as a potential treatment for inflammatory bowel diseases.
Also referred to as 2'-FL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Randomized, placebo-controlled dose-ranging study of 2'-FL in IBD, Crohn's Disease (CD) and ulcerative colitis (UC). The overarching hypothesis is that 2'-FL supplementation in IBD will be safe and well tolerated, while increasing fecal Bifidobacterium abundance and butyrate in a dose dependent manner.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 25
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 11 - 25
- Diagnosed with Crohns Disease or Ulcerative Colitis
- Disease is in remission
You likely can't join if
- Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator.
- Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics
- Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary
- Treatment with another investigational drug or other intervention within 4 weeks
- Treatment with other biologic medication for IBD within prior 12 weeks
- Problem with lactose breakdown
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 11 - 25
- Diagnosed with Crohns Disease or Ulcerative Colitis
- 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
- Not receiving corticosteroids
- 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...
- If receiving mesalamine, mercaptopurine, azathioprine, or methotrexate, must be on a stable dose for at least 12 weeks prior to enrollment.
- 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.
- 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...
- Experienced active IBD clinical disease during the previous six months as determined by the Principal Investigator.
- Use of any of the following medications during the previous month: antibiotics, probiotics or prebiotics
- Diagnosis of celiac disease, diabetes or other co-morbidity that is determined by the PI as being exclusionary
- Treatment with another investigational drug or other intervention within 4 weeks
- Treatment with other biologic medication for IBD within prior 12 weeks
- Problem with lactose breakdown
- Currently pregnant or breast feeding
- 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.
- We will not allow concomitant use of anti-diarrheal medications.
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.