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Single-center, randomized, double-blind, placebo-controlled trail evaluating INF108F in breastfed infants with FPIAP
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INF108F | Experimental | INF108F |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INF108F probiotic | Drug | Oral suspension |
| |
| Placebo |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
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Breastfed infants with FPIAP, w/ either grossly visible bloody stool or microscopic bloody stools, excl. other causes, will be recruited at PNW or MGH Pediatric GI clinic. They will be provided basic information about the study. We will ask potential participants to provide basic contact information and answer some study-specific questions as a pre-qualifier. Individuals who are interested to learn more will receive more details about the study, the informed consent, and study team contacts.
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| ID | Title | Description |
|---|---|---|
| FG000 | INF108F | INF108F |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INF108F | INF108F |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | There will be two analysis populations defined for this study. Analysis of the primary, key secondary, and other secondary endpoints will be completed on the modified Intent-to-Treat (mITT) population. All safety-related tabulations will be based upon the Safety population. The mITT population will include all infants who are randomized and receive at least one supplementation of the intervention. Infants will be analyzed according to the group to which they are randomized. | Posted | Mean | Standard Deviation | Change in %B.infantis reads (Day 28-BL) | Baseline to Day 28 |
|
From baseline to final follow-up study visit, an average of 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INF108F | INF108F | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
This study was a pilot study with a very limited sample size (n=20).
Not all participants were per protocol of the study with the INF108 population having two participants (20%) considered not per protocol and the placebo having one participant (10%) not per protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Qian Yuan | Massachusetts General Hospital | 6172435466 | QYUAN@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2023 | Sep 9, 2025 | Prot_SAP_000.pdf |
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| Drug |
Oral suspension |
|
| 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. | 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. | Baseline, Study Day 7, Study Day 14, Study Day 28 |
| Total |
Total of all reporting groups |
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Weight at birth | Mean | Standard Deviation | kilograms (kg) |
|
| Birth Mode | Count of Participants | Participants |
|
| Singleton delivery | Count of Participants | Participants |
|
| Delivered in a Hospital | Count of Participants | Participants |
|
| Maternal antibiotic exposure during labor/delivery | Count of Participants | Participants |
|
| Highest education of either parent in home is Bachelor's or Advanced degree | Count of Participants | Participants |
|
| Baby ever consumed infant formula | Count of Participants | Participants |
|
| Baby ever consumed infant probiotics | Count of Participants | Participants |
|
| Baby ever consumed solid food | Count of Participants | Participants |
|
| Baby ever consumed iron supplements | Count of Participants | Participants |
|
| Mother ever consumed medication to treat acid reflux of GERD | Count of Participants | Participants |
|
| Acid reflux medication taken after baby was born | Count of Participants | Participants |
|
| Type of Acid Reflux medication consumed | Count of Participants | Participants |
|
| Mother ever had any type of allergy | Count of Participants | Participants |
|
| Type of allergy (mother) | Count of Participants | Participants |
|
| Father ever had any type of allergy | Count of Participants | Participants |
|
| Type of allergy (father) | Count of Participants | Participants |
|
| Age, Customized | Mean | Standard Deviation | Weeks |
|
INF108F
| OG001 | Placebo | Placebo |
|
|
|
| Secondary | 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. | 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. | Posted | Median | Full Range | Scores on a scale | Baseline to day 28 |
|
|
|
|
| Secondary | 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. | Percentage of infants with no gross/visible blood in stool on Study Day 14 via the daily log | Posted | Count of Participants | Participants | Enrollment to Study Day 14 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Study Day 7, Study Day 14, Study Day 28 |
|
|
|
|
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Placebo | Placebo | 0 | 10 | 0 | 10 | 6 | 10 |
|
| Colicky | Gastrointestinal disorders | Non-systematic Assessment | Mild, dose not changed, treatment with conmed |
|
| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
|
| Hematochezia | Gastrointestinal disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
|
| Gas | Gastrointestinal disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
|
| Mild eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Mild, dose not changed, no treatment |
|
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| A small problem |
|
| A moderate problem |
|
| A serious problem |
|
| Missing |
|
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| 0.169 |
| Superiority |
| Day 14 | Cochran-Mantel-Haenszel | 0.168 | Superiority |
| Day 21 | Cochran-Mantel-Haenszel | 0.139 | Superiority |
| Day 28 | Cochran-Mantel-Haenszel | 0.348 | Superiority |