Infantile ColicPhase 2EPICNCT06385054
Effect of Probiotics on Infantile Colic Symptoms
A Phase 2 study testing Probiotic in people with Infantile Colic, run by Lallemand Health Solutions at 10 sites in France.
Trial summary
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 10 sitesFrance
- Study dates
- Aug 2024to Feb 2027
- Phase
- Phase 2
- 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 Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.
- I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
- I5. With a written informed consent signed by the father and mother or legal guardian.
- I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.
- I7. At least one of the legal representatives is affiliated with a social security scheme.
Who cannot join
- E1. Birthweight < 2500 g. E2. Gestational age < 37 weeks. E3. Apgar score at 5 minutes < 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.
- E5. Stunted growth/weight loss (< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.
- E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.
- E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.
- E15. Use of anti-colic medication at any time from birth to the moment of screening.
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- E16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.
- E17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.
- E18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.
- E19. Impossibility to contact the legal representatives in case of emergency.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Basile Frilley contact
10 sites in 1 country
France10 sites, 10 recruiting
- Not yet recruiting
Cabinet privé Dr Regimbart-Trubuil Christine
Bécon-les-Granits, 49370
Christine Regimbart-Trubuil, MD
- Recruiting
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200
Mohamad Hage, MD
- Not yet recruiting
CHU Caen Normandie
Caen, 14033
Edouard Lacotte, MD
- Not yet recruiting
CHU Grenoble Alpes
La Tronche, 38700
Ellen Katranji, MD
- Recruiting
Hôpital Saint Vincent de Paul
Lille, 59000
Pr. Nicholas Kalach, MD
- Not yet recruiting
Centre Hospitalier de Montauban
Montauban, 82000
Sabine Charpentier, MD
- Not yet recruiting
CHU de NANTES
Nantes, 44000
Hugues Piloquet, MD
- Not yet recruiting
Biofortis, Unité d'investigation Clinique
Paris, 75012
Stéphanie Cavigoli, MD
- Not yet recruiting
Biofortis, Unité d'investigation Clinique
Saint-Herblain, 44800
Isabelle Metreau, MD
- Recruiting
Centre Hospitalier du val d'Ariège
Saint-Jean-de-Verges, 09000
Lucas Percheron, MD
About this study
Official title: Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.
Read the detailed description
The goal of this clinical trial is to evaluate the potential beneficial effects of B. lactis B94 on the symptoms of infantile colic.
Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 3 in-person visits and 4 phone calls.
- Conditions
- Infantile Colic
- Being tested
- Probiotic, Placebo
- Keywords
- EPIC, Infant Colic, Probiotics, Crying Time, Gut Microbiota, Sleep Duration
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
PlaceboDietary supplement
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants in this group will be randomized to receive a placebo for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily crying duration
Proportion of infants who experience a decrease of mean daily crying duration of at least 50% after 4 weeks of intervention, in placebo versus probiotic groups.
Measured: 4 weeks
Secondary outcomes (6)
Change in crying patterns
Proportion of infants who experience a decrease of mean daily crying duration of at least 50% or at least 25%, mean daily number of crying episodes and variation in mean daily crying duration after 1, 2, 3, 4 weeks of intervention, in placebo versus probiotic groups.
Measured: 4 weeks
Change in sleep duration
Variation in the mean daily duration of the infant's sleep after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.
Measured: 4 weeks
Change in maternal quality of life
Variation in the maternal score of the mother quality-of-life questionnaire (SF- 36) after 4 weeks of intervention in probiotic versus placebo groups.
Measured: 4 weeks
Change in bowel habits
General perception of colic evolution (total recovery / better / worse / no change), infant bowel movement frequency (mean daily number of stools) and stool consistency (rate (%), Amsterdam infant stool scale) after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.
Measured: 4 weeks
Change in gut microbiota composition
Gut microbiota composition (α-diversity, β-diversity, and relative abundance at the genus level) and variation in gut microbiota composition (α-diversity, β-diversity, and relative abundance at the genus level) after 4 weeks of intervention in probiotic versus placebo groups (via 16S sequencing).
Measured: 4 weeks
Probiotic strain recovery
Recovery of the probiotic strain in infant stool samples (qPCR) after 4 weeks of intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Pr. Nicholas Kalach, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385054
- Sponsor's protocol ID
- L-027
- Other IDs
- 2023-A02612-43, PEC23063
- Acronym
- EPIC
- Status last verified
- Aug 2024
- First submitted
- 23 Apr 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
- ClinicalTrials.gov ID
- NCT06385054
- Acronym / sponsor ID
- EPIC / L-027
- Conditions
- Infantile Colic
- Keywords
- EPIC, Infant Colic, Probiotics, Crying Time, Gut Microbiota, Sleep Duration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.
Detailed description
The goal of this clinical trial is to evaluate the potential beneficial effects of B. lactis B94 on the symptoms of infantile colic.
Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 3 in-person visits and 4 phone calls.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will be randomized to receive a placebo for 4 weeks. |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.
- I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
- I5. With a written informed consent signed by the father and mother or legal guardian.
- I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.
- I7. At least one of the legal representatives is affiliated with a social security scheme.
Key exclusion criteria (10 listed)
- E1. Birthweight < 2500 g. E2. Gestational age < 37 weeks. E3. Apgar score at 5 minutes < 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.
- E5. Stunted growth/weight loss (< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.
- E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.
- E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.
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 |
|---|---|---|
| ProbioticParticipants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water. | Dietary supplement | Probiotic |
| PlaceboParticipants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water. | Dietary supplement | Placebo |
Primary outcome
Change in daily crying duration
Time frame: 4 weeks
Proportion of infants who experience a decrease of mean daily crying duration of at least 50% after 4 weeks of intervention, in placebo versus probiotic groups.
6 secondary outcomes
Change in crying patterns
Time frame: 4 weeks
Change in sleep duration
Time frame: 4 weeks
Change in maternal quality of life
Time frame: 4 weeks
Change in bowel habits
Time frame: 4 weeks
Change in gut microbiota composition
Time frame: 4 weeks
Probiotic strain recovery
Time frame: 4 weeks
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 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Basile Frilley contact
Pr. Nicholas Kalach, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Infantile Colic, run by Lallemand Health Solutions at 10 sites in France.
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 5 inclusion and 10 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lya Blais, M.Sc. (+ 1-514-283-1387, lblais@lallemand.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily crying duration (time frame: 4 weeks). 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 16 Aug 2024.