COMPLETED

INF108F in Infants With Food Protein Induced Proctocolitis

Conditions

Infant Development Gut Microbiome Food Protein Induced Allergic Proctocolitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP

Official Title

Restoring Gut Health With INF108F in Infants With Food Protein Induced Allergic Proctocolitis

Quick Facts

Study Start:2023-09-09

Study Completion:2024-09-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05793112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 90 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Newton Wellesley Hospital

Newton, Massachusetts, 02462

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-09

Study Completion Date2024-09-27

Study Record Updates

Study Start Date2023-09-09

Study Completion Date2024-09-27

Terms related to this study

Additional Relevant MeSH Terms

Infant Development
Gut Microbiome
Food Protein Induced Allergic Proctocolitis