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Probiotic

INF108F Probiotic for Food Protein-Induced Allergic Proctocolitis (RESTORE Trial)

Phase 4

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 28

Awards & highlights

RESTORE Trial Summary

This trial tested a drug, INF108F, to treat FPIAP in breastfed infants. It was carefully designed and monitored.

Who is the study for?

This trial is for breastfed infants aged 1-90 days with Food Protein Induced Allergic Proctocolitis (FPIAP), showing blood in stool without other causes. Infants must be born full-term and receive at least half of their nutrition from breastfeeding. Those with medical complications, prior surgeries, recent antibiotic use, or exposure to certain probiotics are excluded.Check my eligibility

What is being tested?

The study tests the effects of INF108F probiotic on infants with FPIAP against a placebo. It's a single-center trial where participants are randomly assigned to either the probiotic or placebo group without knowing which one they're receiving (double-blind).See study design

What are the potential side effects?

While specific side effects aren't listed here, common side effects of probiotics can include digestive discomfort such as gas or bloating. Since this involves infants, close monitoring for any adverse reactions will be essential.

RESTORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My infant has FPIAP with blood in their stool and no other causes.

RESTORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes to gut microbiome composition

Secondary outcome measures

Changes to clinical symptoms of FPIAP

RESTORE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INF108FExperimental Treatment1 Intervention

INF108F

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,468 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential hazards of INF108F when administered to patients?

"This treatment has been given the green light, so INF108F is ranked a 3 on the safety scale."

Answered by AI

Are applicants below the age of forty considered for inclusion in this experiment?

"This trial is seeking patients of a very specific age range, from one day to three months old. Additionally, there are 35 clinical trials involving minors and 21 for seniors."

Answered by AI

Is this experiment open to new participants?

"Affirmative. According to clinicaltrials.gov, this trial which was first posted on September 9th 2023 is recruiting participants at present time. This data has most recently been updated on October 24th 2023 and 200 patients are required from a single medical centre."

Answered by AI

How many subjects are involved in this clinical research?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical trial began on September 9th 2023 and was recently updated on October 24th 2023, and the research is open to 200 participants at 1 study site."

Answered by AI

Who has the requisite qualifications to be accepted into this investigation?

"This medical trial seeks two-hundred patients aged between 0 and 90 days who have a documented gut microbiome. Eligible candidates must be infants, both male and female, of any ethnic/racial origin with gestational periods ranging from 37 to 42 weeks; those that are exclusively breastfed or predominantly so qualify as well. Finally, the consent form needs to be signed by either their legal guardian electronically or in ink."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

INF108F in Infants With Food Protein Induced Proctocolitis

Qian Yuan, MD, PhD 2023. "INF108F in Infants With Food Protein Induced Proctocolitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05793112.

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