INF108F in Infants With Food Protein Induced Proctocolitis

Infant Development Clinical Trial

— RESTORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793112
• Other study ID #: 2022P002752
• Status: Recruiting
• Phase: Phase 4
• Start date: September 9, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Arsal Khan, BA
• Phone: 617-643-8298
• Email: akhan51[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a single-center, randomized, double-blind, placebo-controlled trial with two arms evaluating IBF108F in breastfed infants with FPIAP. Assessments will be conducted over a 4-week study period with assessment of blood in stool, infant stooling, sleep, feeding, and growth. Safety will be evaluated through collection adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Infant Development
• Proctocolitis

Intervention

Drug:
• INF108F probiotic
Oral suspension
• Placebo
Oral suspension

Locations

Country	Name	City	State
United States	Newton Wellesley Hospital	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Martin VM, Virkud YV, Phadke NA, Su KW, Seay H, Atkins MR, Keet C, Shreffler WG, Yuan Q. Increased IgE-Mediated Food Allergy With Food Protein-Induced Allergic Proctocolitis. Pediatrics. 2020 Sep;146(3):e20200202. doi: 10.1542/peds.2020-0202. No abstract — View Citation

Martin VM, Virkud YV, Seay H, Hickey A, Ndahayo R, Rosow R, Southwick C, Elkort M, Gupta B, Kramer E, Pronchick T, Reuter S, Keet C, Su KW, Shreffler WG, Yuan Q. Prospective Assessment of Pediatrician-Diagnosed Food Protein-Induced Allergic Proctocolitis — View Citation

Radano MC, Yuan Q, Katz A, Fleming JT, Kubala S, Shreffler W, Keet CA. Cesarean section and antibiotic use found to be associated with eosinophilic esophagitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):475-477.e1. doi: 10.1016/j.jaip.2014.02.018. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes to gut microbiome composition	Changes to the gut microbiome composition in infants with FPIAP over a 4-week period. We will analyze the 16S rRNA of the gut microbiome as well as the short-gun sequencing of metagenomic species of the gut microbiome	Baseline to Day 28
Secondary	Changes to clinical symptoms of FPIAP	Changes to clinical symptoms of FPIAP, specifically we will collect information using questionnaire about infants' GER symptoms, feeding, sleep and stool frequency and consistency. The severity of GER will be quantified using the Infant GER Questionnaire (I-GERQ), with numeric scores, the higher score means more severe GER, the maximum score is 25, scores >7 provide 74% specificity and 94% sensitivity for diagnosing GERD. The sleep will be captured using Infant Sleep Questionnaire, with 0-10 scales, 0 means worst sleep and 10 means excellent sleep for quantify the quality of infant's night sleep.	Baseline to day 28