Evaluating a probiotic treatment for infants with food protein induced proctocolitis
Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis
This study is testing a probiotic treatment for breastfed infants with food protein induced proctocolitis to see if it helps improve their symptoms and overall well-being.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 90 Days |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Newton, Massachusetts) |
| Trial ID | NCT05793112 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, randomized, double-blind, placebo-controlled evaluation of INF108F, a probiotic treatment, in breastfed infants diagnosed with food protein induced allergic proctocolitis (FPIAP). Over a 4-week period, the study will assess various outcomes including the presence of blood in stool, infant stooling patterns, sleep quality, feeding habits, and growth metrics. Safety will be monitored through the collection of adverse events during the trial. The goal is to determine the efficacy of INF108F in improving symptoms associated with FPIAP.
Who should consider this trial
Good fit: Ideal candidates for this study are breastfed infants aged 1 to 90 days with a documented diagnosis of FPIAP.
Not a fit: Infants who are exclusively formula-fed or have other severe medical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the health and well-being of infants suffering from FPIAP.
How similar studies have performed: While this approach is novel in the context of FPIAP, similar probiotic interventions have shown promise in other gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants, male or female, of all ethnic/racial groups, with a gestational period of 37 to 42 weeks * Infants aged 1 - 90 days old with a documented FPIAP with either gross blood or microscopic blood in without other possible causes * Infants must be exclusively breastfed or at least half of oral intake is from breast feeding or from expressed breast milk * A willing parent or legal guardian will sign the consent form either electronically or with a wet ink signature Exclusion Criteria: * Infants born earlier than 37 weeks of gestation * Infants who are exclusively formula-fed or less than half of oral intake is from breastfeeding or from expressed breast milk at the time of enrollment * Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies) * Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions, gastrointestinal inflammatory conditions, or renal insufficiency * History of abdominal surgery or congenital abnormalities of the GI track, the cardiovascular system, the pulmonary system or the renal system * Antibiotic use (oral or systemic) within 7 days prior to enrollment * Mother's intent to feed non-study probiotics or solid food to their infant at any time during the study * Mothers with substance use disorder (SUD) or on Nicotine replacement therapy (NRT) * Infants who have consumed any B. infantis-containing probiotics since birth
Where this trial is running
Newton, Massachusetts
- Newton Wellesley Hospital — Newton, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Arsal Khan, BA
- Email: akhan51@mgh.harvard.edu
- Phone: 617-643-8298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.