INF108F in Infants With Food Protein Induced Proctocolitis (RESTORE)

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

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

Study Overview

• Status: Completed
• Conditions: Infant Development; Gut Microbiome; Food Protein Induced Allergic Proctocolitis
• Intervention / Treatment: Drug: Placebo; Drug: INF108F probiotic

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02462
      • Newton Wellesley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral suspension
Experimental: INF108F	Drug: INF108F probiotic; Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to Gut Microbiome Composition	Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).	Baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log	Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.	Enrollment to Study Day 14
Changes to Clinical Symptoms of FPIAP	We will collect information using questionnaires about infants' gastroesophageal reflux disease symptoms, feeding, sleep and stool frequency and consistency. The severity of infant GER will be quantified using the Infant Gastroesophageal Reflux Questionnaire (I-GERQ), with numeric scores. The minimum score is 0 and the maximum score is 25; scores >7 provide 74% specificity and 94% sensitivity for diagnosing GERD. Higher I-GERQ scores/values are indicative of worse outcomes, worse reflux symptoms for the infant. The secondary outcome was reported as the absolute change from baseline in I-GERQ score; therefore, a higher value would be positive as the score is reduced significantly from baseline, which means reflux symptoms were improved.	Baseline to day 28
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log	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. Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.	Baseline, Study Day 7, Study Day 14, Study Day 28

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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 by Gross or Occult Blood. J Allergy Clin Immunol Pract. 2020 May;8(5):1692-1699.e1. doi: 10.1016/j.jaip.2019.12.029. Epub 2020 Jan 7.
• 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 available.
• 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. Epub 2014 May 1. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2023
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colitis; Sigmoid Diseases; Proctitis; Proctocolitis
• Other Study ID Numbers: 2022P002752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No