Infantile ColicCTBE2503NCT07148583
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
A study testing BioAmicus Complete in people with Infantile Colic and Gastroesophageal Reflux (GER), run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 24 months
- Conditions the study is for
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation
- What is being tested?
- BioAmicus Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Sep 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-24 months at enrollment.
- Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged suitable for study participation.
- Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection, if applicable).
- Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.
Who cannot join
- Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).
- Clinically unstable condition or severe/critical illness that could interfere with participation or safety in the opinion of the investigator.
- Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.
- History of severe allergy or hypersensitivity to components of the investigational product.
- Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
- Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Van Anh Tran, MSc.Pharm, 0343035492, tvanh@hpmu.edu.vn
Phuong Thi Thu Nguyen, MD, PhD, nttphuong@hpmu.edu.vn
About this study
Official title: Evaluation of the Efficacy and Safety of the Multistrain Probiotic "BioAmicus Complete" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea, Dysbiosis
- Being tested
- BioAmicus Complete, Usual Care (No Probiotic)
- Keywords
- BioAmicus Complete, probiotic, multistrain probiotic, infant, functional gastrointestinal symptoms, Infant Gastrointestinal Symptom Questionnaire, gut microbiome, stool microbiome
- Medical subject headings
- Colic, Gastroesophageal Reflux, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioAmicus CompleteDietary supplement
Also called Multistrain Probiotic (BioAmicus Complete)
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.
Usual Care (No Probiotic)Other
Also called Standard care, Routine clinical management
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.
| Study group | Role | What they receive |
|---|---|---|
| BioAmicus Complete + Usual Care | Experimental | 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. Receives: Dietary Supplement: BioAmicus Complete; Other: Usual Care (No Probiotic) |
| Usual Care Alone | Active comparator | 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. Receives: Other: Usual Care (No Probiotic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline to Day 42
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start5 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, single-center trial in infants 0-24 months comparing BioAmicus Complete plus usual care versus usual care.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148583
- Sponsor's protocol ID
- CTBE.25.03
- Other IDs
- Protocol No.: CTBE.25.03
- Acronym
- CTBE2503
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Multistrain Probiotic "BioAmicus Complete" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial
- ClinicalTrials.gov ID
- NCT07148583
- Acronym / sponsor ID
- CTBE2503 / CTBE.25.03
- Conditions
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea, Dysbiosis
- Keywords
- BioAmicus Complete, probiotic, multistrain probiotic, infant, functional gastrointestinal symptoms, Infant Gastrointestinal Symptom Questionnaire, gut microbiome, stool microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, single-center trial in infants 0-24 months comparing BioAmicus Complete plus usual care versus usual care.
| Arm | Type | Receives |
|---|---|---|
| BioAmicus Complete + Usual Care | Experimental | Dietary Supplement: BioAmicus Complete, Other: Usual Care (No Probiotic)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. |
| Usual Care Alone | Active comparator | 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. |
Who may qualify
- Ages
- 0 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 0-24 months at enrollment.
- Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged suitable for study participation.
- Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection, if applicable).
- Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.
Key exclusion criteria (7 listed)
- Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).
- Clinically unstable condition or severe/critical illness that could interfere with participation or safety in the opinion of the investigator.
- Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.
- History of severe allergy or hypersensitivity to components of the investigational product.
- Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioAmicus CompleteAlso: Multistrain Probiotic (BioAmicus Complete)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. | Dietary supplement | BioAmicus Complete + Usual Care |
| Usual Care (No Probiotic)Also: Standard care, Routine clinical managementStandard 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. | Other | BioAmicus Complete + Usual Care, Usual Care Alone |
Primary outcome
Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42
Time frame: Baseline to 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
Stool Microbiome - Change in Alpha Diversity (Shannon, Chao1)
Time frame: Baseline to Day 42
16S rRNA gene sequencing of stool at baseline and Day 42; alpha diversity indices computed and change analyzed within and between groups.
5 secondary outcomes
Change in Stool Frequency Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Stool Consistency Using the Brussels Infant and Toddler Stool Scale (BITSS) from Baseline to Day 42
Time frame: Up to Day 42
Stool Microbiome - Between-Group Difference in Beta Diversity (PERMANOVA)
Time frame: Day 42
Change in Frequency of Regurgitation and Vomiting Episodes from Baseline to Day 42
Time frame: Baseline to Day 42
Change in Colic Symptoms Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42
Time frame: Baseline to Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioAmicus Complete in people with Infantile Colic and Gastroesophageal Reflux (GER), run by Haiphong University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nguyen Thi Thu Phuong, MD, PhD (+84936685007, nttphuong@hpmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42 (time frame: Baseline to Day 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.