2'-Fucosyllactose for Ileocolitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Ileocolitis+3 More
2'-Fucosyllactose - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a specific type of fiber may help treat inflammatory bowel disease.

See full description

Eligible Conditions

  • Ileocolitis
  • Inflammatory Bowel Diseases
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 2'-Fucosyllactose will improve 1 primary outcome and 1 secondary outcome in patients with Ileocolitis. Measurement will happen over the course of 20 weeks.

20 weeks
Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo
Mean fecal Bifidobacterium abundance in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

2'-Fucosyllactose
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 216 total participants across 2 different treatment groups

This trial involves 2 different treatments. 2'-Fucosyllactose is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

2'-Fucosyllactose
Drug
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)
Placebo
Other
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)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 20 weeks for reporting.

Closest Location

Cincinnati Children's Hospital Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What is the average age someone gets inflammatory bowel diseases?

"While the lifetime risk of Crohn's disease remains very low, the lifetime risk of UC increases considerably over age 50. There appears to be some variation with ethnicity, gender, and region." - Anonymous Online Contributor

Unverified Answer

Is 2'-fucosyllactose safe for people?

"It seems that when administered in a low dose (150 mg/kg/day) and given consistently over two years, FSL is safe for children and adolescents with IBD." - Anonymous Online Contributor

Unverified Answer

What causes inflammatory bowel diseases?

"Results from a recent paper gives some insights into IBDs based on the theory that they result from a combination of environmental, dietary and genetic factors." - Anonymous Online Contributor

Unverified Answer

Can inflammatory bowel diseases be cured?

"At present IBD therapies can delay and/or prevent disease recurrence, but are ineffective in arresting new lesions and preventing inflammation from occurring. A novel target for the treatment of inflammatory bowel disease in the future is the regulation of the mucosal immune response." - Anonymous Online Contributor

Unverified Answer

What is inflammatory bowel diseases?

"Inflammatory bowel diseases (IBD) are debilitating diseases that affect the colon by making the colon inflamed. In recent years there has been an increasing number of reports of IBD in children and adolescents in the western world. Results from a recent clinical trial, pediatric patients and general physicians were asked what is IBD? answer: Most physicians mistakenly thought that IBD is a rare disease in childhood. Physicians' education about IBD and its symptoms is therefore greatly needed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for inflammatory bowel diseases?

"There is no one treatment option for IBD that is used by all patients. The most recent data has focused on the use of 5-aminosalicylates. The use of these agents did not differ by patient characteristic, but patients with more extensive disease were less likely to be receiving 5-ASA at initiation of treatment. Data from older studies shows that more aggressive therapies can be effective. A trial of medical therapy alone can lead to cure in about 5% of patients with UC or CD. In UC, surgery and anti-TNF therapy can prevent endoscopic and clinical relapse in about a third of patients. In CD, anti TNF therapy is effective in preventing relapse in about 50% of patients." - Anonymous Online Contributor

Unverified Answer

How many people get inflammatory bowel diseases a year in the United States?

"The rate of chronic disease occurrence in the United States is increasing. The proportion of the population affected is estimated to remain fairly stable between 2005 and 2015. Although these estimates were not based on IBD-related deaths or hospital utilization, they may serve as a reasonable estimate for estimating the burden of this chronic disorder in the U.S. population." - Anonymous Online Contributor

Unverified Answer

What are the signs of inflammatory bowel diseases?

"There are many signs of autoimmune diseases such as arthritis, skin rashes and unexplained weight loss. There are many signs of inflammatory bowel diseases, including the gastrointestinal symptoms such as constipation and diarrhea. Anemia, hypothyroidism, and chronic fatigue may also be signs of inflammatory bowel disease." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of 2'-fucosyllactose?

"This case highlights the potential for an unexpected adverse reaction to a non-allergenic dietary fibre which, in the majority of individuals, does not cause an allergic reaction." - Anonymous Online Contributor

Unverified Answer

Does 2'-fucosyllactose improve quality of life for those with inflammatory bowel diseases?

"Data from a recent study of the meta-analysis indicated that FL may improve quality of life for patients with IBD. Further large-scale trials are warranted to confirm the clinical benefits of FL for IBD patients." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating inflammatory bowel diseases?

"More than 45% of the patients with inflammatory bowel diseases treated with conventional therapies have a nonrespond. A substantial number never progress to endoscopy or respond. The use of specific biologic agents to prevent the onset and/or progression of inflammatory bowel disease can benefit these patients but requires larger, prospective studies to determine the indications." - Anonymous Online Contributor

Unverified Answer

What does 2'-fucosyllactose usually treat?

"Dietary supplements may be an effective treatment for patients with IBD who have significant symptoms. However, research is needed before these supplements can be used in clinical practice." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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