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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
Must not have
Infants born earlier than 37 weeks of gestation
Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 28
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My infant has FPIAP with blood in their stool and no other causes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My baby was born before 37 weeks of pregnancy.
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I do not have severe autoimmune, chronic inflammation, or kidney problems.
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I am a mother with a substance use disorder or using nicotine replacement therapy.
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My infant has taken B. infantis probiotics since birth.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes to gut microbiome composition
Secondary study objectives
Changes to clinical symptoms of FPIAP

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: INF108FExperimental Treatment1 Intervention
INF108F
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,745 Total Patients Enrolled
~89 spots leftby Dec 2025
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