Infant DevelopmentPhase 4RESTORENCT05793112
INF108F in Infants With Food Protein Induced Proctocolitis
A Phase 4 study testing INF108F probiotic in people with Infant Development and Gut Microbiome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP Read more about this study
- Who is it for?
- Ages 1 day to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Gut Microbiome, Food Protein Induced Allergic Proctocolitis
- What is being tested?
- INF108F probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2023to 27 Sep 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: 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
Read the 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.
- Being tested
- INF108F probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INF108F probioticDrug
Oral suspension
PlaceboDrug
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| INF108F | Experimental | INF108F Receives: Drug: INF108F probiotic |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Day 28
Secondary outcomes (3)
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.
Measured: Baseline to day 28
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.
Measured: Enrollment to Study Day 14
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.
Measured: Baseline, Study Day 7, Study Day 14, Study Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start9 Sep 2023
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Yuan, MD, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793112
- Sponsor's protocol ID
- 2022P002752
- Acronym
- RESTORE
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2023
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No