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| Name | Class |
|---|---|
| Broad Institute of MIT and Harvard | OTHER |
| University of Cincinnati | OTHER |
| Connecticut Children's Medical Center | OTHER |
| Nationwide Children's Hospital |
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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. The investigators will test 1, 5, or 10 gm 2'-FL compared to 2 gm dextrose placebo as a daily dietary supplement in pediatric and young adult IBD participants in stable remission receiving infliximab, adalimumab, or infliximab-dyyb biosimilar anti-TNF therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2'-Fucosyllactose | Experimental | Phase I: 36 young adult participants aged 18-25 years. Group 1: 1 gm per day n=12 (6UC/6CD) Group 2: 5 gm per day n=12 (6UC/6CD) Group 3: 10 gm per day n=12 (6UC/6CD) Phase II (post Phase I interim safety analysis): 120 participants aged 11-25 years Group 1: 1 gm per day n=40 (20UC/20CD) Group 2: 5 gm per day n=40 (20UC/20CD) Group 3: 10 gm per day n=40 (20UC/20CD) |
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| Placebo | Placebo Comparator | Phase I: 20 young adult participants age 18-25 years dosed at 2 gm placebo per day. (10UC/10CD) Phase II (post Phase I interim safety analysis): 40 participants age 11-25 years dosed at 2 gm placebo per day. (20UC/20CD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2'-Fucosyllactose | Drug | Human milk oligosaccharide prebiotic dietary supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo | Measured by the Gastrointestinal Symptom Rating Scale (GSRS). The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire for patients with GI symptoms. Patients are asked to numerically score their subjective symptoms on a scale of 1-7 (1=no discomfort up to 7=severe discomfort). The sum of the scores for all 15 items is regarded as the GSRS total score | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo | Measured by fecal DNA 16S ribosomal sequencing | 20 weeks |
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Inclusion 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
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 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.
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 post-surgery.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramona Bezold, BSN | Contact | 1-(513)-636-1412 | Ramona.Bezold@cchmc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06106 | United States |
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| OTHER |
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| Placebo | Other | Dextrose |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| C031420 | 2'-fucosyllactose |
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