An interventional study of BioAmicus Complete and Usual Care (No Probiotic) in Infantile Colic, Gastroesophageal Reflux (GER) and Functional Constipation, sponsored by Haiphong University of Medicine and Pharmacy. Recruiting at 1 site in Vietnam. Open to participants aged 0 Days to 24 Months. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Haiphong University of Medicine and Pharmacy · Not applicable, Interventional, and Supportive care
Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.
The primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic/regurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety/tolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.
caregiver burden and health care visits. Modulating the developing gut microbiome with probiotics may alleviate these symptoms. BioAmicus Complete is a multistrain probiotic designed to support a healthy intestinal microbiota; systematic clinical evaluation is warranted to determine its efficacy and safety in infants.
Objectives:
Primary: Determine whether BioAmicus Complete improves overall gastrointestinal symptoms versus usual care, measured by change in IGSQ total score between baseline and study end.
Exploratory (microbiome): Characterize changes in stool microbiome composition and diversity across the study period.
Secondary: Compare groups on symptom domain scores (e.g., colic, regurgitation, stooling patterns), caregiver burden/quality of life, health care utilization and antibiotic exposure, growth parameters, and safety outcomes (adverse events, serious adverse events, and product-related events).
Significance: Findings will inform whether BioAmicus Complete can be recommended as an adjunct to routine care for infant functional gastrointestinal symptoms and will provide preliminary insights into microbiome changes associated with symptom improvement.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's planned enrollment of 110 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Haiphong University of Medicine and Pharmacy is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol/label for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.
Dietary Supplement: BioAmicus Complete · Other: Usual Care (No Probiotic)
Participants receive standard clinical management per local practice for infant functional gastrointestinal symptoms. No probiotic supplementation is provided (participants are asked to avoid other probiotic products during the study). Concomitant medications and supportive care may be used as clinically indicated at the investigator's discretion.
Other: Usual Care (No Probiotic)
Oral liquid probiotic (multistrain) administered by caregivers per protocol/label for 42 days to infants with functional GI symptoms. Given as drops by mouth; dosing and administration instructions per protocol. No other probiotic products allowed during the study. Concomitant medications and routine management may be used as clinically indicated. Adherence is recorded; lot/batch number captured.
Also known as: Multistrain Probiotic (BioAmicus Complete)
Standard clinical management for infant functional gastrointestinal symptoms per local practice. No probiotic supplementation is provided during the study period. Participants follow the same visit and assessment schedule as the intervention arm. Concomitant medications and supportive care may be used as clinically indicated.
Also known as: Standard care, Routine clinical management
Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42
IGSQ is a 13-item, caregiver-reported questionnaire (total score 13-65; higher scores indicate worse symptoms). Change is calculated as Day 42 minus baseline; a negative change indicates improvement
Time frame: Baseline to Day 42
Stool Microbiome - Change in Alpha Diversity (Shannon, Chao1)
16S rRNA gene sequencing of stool at baseline and Day 42; alpha diversity indices computed and change analyzed within and between groups.
Time frame: Baseline to Day 42
Change in Stool Frequency Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42
Stool frequency is assessed. Responses range from 1 (≤2 times/week) to 5 (\>3 times/day). Higher scores indicate more frequent bowel movements (diarrhea tendency), while lower scores indicate infrequent stools (constipation). Improvement is defined as movement toward the normal category (1 bowel movement/day).
Time frame: Baseline to Day 42
Change in Stool Consistency Using the Brussels Infant and Toddler Stool Scale (BITSS) from Baseline to Day 42
Stool consistency is assessed using the Brussels Infant and Toddler Stool Scale (BITSS), with five categories: 1 = watery, 2 = soft, 3 = formed, 4 = hard, 5 = inconsistent. Category 3 (formed) is considered normal. Scores below 3 represent looser stools (diarrhea tendency), while scores above 3 represent harder stools (constipation tendency). Improvement is defined as a ≥1-category change toward formed stool.
Time frame: Up to Day 42
Stool Microbiome - Between-Group Difference in Beta Diversity (PERMANOVA)
Bray-Curtis and UniFrac distances used to assess community differences between groups; hypothesis testing via PERMANOVA.
Time frame: Day 42
Change in Frequency of Regurgitation and Vomiting Episodes from Baseline to Day 42
Regurgitation and vomiting are assessed using Questions. Frequency is reported on a 7-point ordinal scale (0 = never to 6 = \>5 times/day). Higher scores indicate more frequent regurgitation/vomiting (worse outcome). Improvement is defined as a reduction of ≥1 category on the frequency scale.
Time frame: Baseline to Day 42
Change in Colic Symptoms Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42
Colic is assessed, based on Wessel's criteria (≥3 hours/day, ≥3 days/week, for ≥3 weeks). Responses are scored on a binary scale (Yes/No). Presence of colic is considered a positive outcome at baseline. Improvement is defined as resolution of criteria (reduction below threshold)
Time frame: Baseline to Day 42
Plan to share: Yes — De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared. Datasets will include: baseline characteristics; IGSQ item and total scores; caregiver diary data (stool frequency/form, regurgitation/vomiting counts, crying/irritability duration); growth parameters; concomitant medications; protocol deviations; and safety data (TEAEs/SAEs, relatedness, severity). For microbiome analyses, processed data (e.g., feature/ASV tables, relative abundance matrices, and diversity indices) will be shared; raw sequencing reads may be available on justified request. A data dictionary and variable codebook will accompany the IPD.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting materials will become available \~6 months after publication of the primary results and will remain available for 36 months thereafter. Earlier access may be granted for bona fide regulatory or public health needs. Extensions beyond 36 months will be considered upon reasonable request.
Access criteria: Access is available to qualified researchers with a methodologically sound proposal and, where applicable, IRB/ethics approval or waiver. Submit requests to the study contacts listed in this record, including a brief proposal and analysis plan. Approved requestors must sign a Data Use Agreement; data will be provided via secure transfer. Data may be used only for the approved objectives; re-identification is prohibited; citation of the original study is required; data must be destroyed or returned at the end of the access period.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Apr 2026, 7 months after the start.
Of 32 non-industry interventional studies with no phase under Colic, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 44 studies reached it within 21 months; a quarter within 10 and three quarters within 40.
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Haiphong University of Medicine and Pharmacy