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2'-FL Supplement for Inflammatory Bowel Disease (PRIME Trial)
PRIME Trial Summary
This trial is testing whether a supplement called 2'-FL is safe and effective in treating inflammatory bowel diseases like Crohn's Disease and ulcerative colitis. 1, 5, or 10 gm of 2'-FL will be given daily compared to a placebo to see if it increases the abundance of good bacteria and butyrate in the gut.
PRIME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRIME Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRIME Trial Design
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Who is running the clinical trial?
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- I do not have celiac disease, diabetes, or any other condition that the study leader would exclude.My child's Crohn's disease is mild.I am 18-25 years old with mild Crohn's disease symptoms.I have lactose intolerance.I have been diagnosed with Crohn's Disease or Ulcerative Colitis.I am between 11 and 25 years old.I have been on a consistent dose of anti-TNF medication for 12 weeks.I haven't taken biologic medication for IBD in the last 12 weeks.My condition is currently in remission.I am not taking corticosteroids.I am an adult with UC and currently have no blood in stool or increased stool frequency.I have Crohn's disease, had one surgery removing part of my small intestine and colon, and it's been 6 months since.I have been on a stable dose of specific medications for at least 12 weeks.I am aged 11-17 with mild ulcerative colitis symptoms.You have had a flare-up of your inflammatory bowel disease (IBD) in the past six months, as determined by the study doctor.I have not taken antibiotics, probiotics, or prebiotics in the last month.I have Crohn's disease but haven't had more than one surgery for it, and I don't have ulcerative colitis with any related surgery.I am not taking any anti-diarrheal medications.
- Group 1: Placebo
- Group 2: 2'-Fucosyllactose
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there openings for potential participants in this experiment?
"That is correct. According to the information on clinicaltrials.gov, this trial continues to search for participants and was initially posted in September 2019. It has since been updated as recently as January 2022, recruiting a total of 216 patients at three different sites."
Have any other investigations delved into the potential of 2'-Fucosyllactose?
"Currently, two studies exploring the efficacy of 2'-Fucosyllactose are underway. Neither study has reached phase 3 yet; however, several trials are occurring in Cincinnati and a total of four sites are involved with these research projects."
Is it possible to register for this research trial?
"This clinical trial is open to 216 individuals afflicted with ileocolitis between the ages of 11 and 25. The important requirements for applicants are: willingness to comply, CDAI score (if aged 18-25), signed informed consent form, gender identification, remission status from Crohn's disease or Ulcerative colitis (depending on age group), wPCDAI sub-score (for those aged 11-17) and PUCAI score if under 17 as well as no current steroid use."
To what extent has this medical research been populated with participants?
"Affirmative. The particulars on clinicaltrials.gov demonstrate that this experiment, established on September 20th 2019, is currently seeking volunteers. A total of 216 subjects are expected to be recruited from 3 sites."
Is this research available to those under the age of sixty?
"Qualified candidates for this trial ought to be between eleven and twenty-five years of age. In comparison, there are 119 trials catered towards those under eighteen while 386 studies serve patients above 65 years old."
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