Infant ColicPhase 2NCT03467334
Infant Colic Treatment With Probiotics
A Phase 2 study testing B. breve, B. breve plus L. fermentum and Simethicone 20 MG in people with Infant Colic, run by Mónica Olivares Martín; PhD at 1 site in Spain.
Trial summary
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. Read more about this study
- Who is it for?
- Ages 3 to 12 weeks
- Conditions the study is for
- Infant Colic
- What is being tested?
- B. breve, B. breve plus L. fermentum and Simethicone 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2017to 15 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants from 3 to 12 weeks of age
- Born at least at week 34
- Birth weight equal to or greater than 2000 grams
- Fulfill the criteria of Rome III
- Informed consent signed by parents or guardians
Who cannot join
- Failure to thrive
- Antibiotic treatment less than 2 weeks before the study or during the study
- Take probiotics as a treatment, different from the one that could contain the powdered infant formula
- Abandon breastfeeding and switch to infant formula
- Failure to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.
Read the detailed description
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.
The objective of the present study is to compare the effect of B. brevis and B. brevis\L mixture. fermentum with respect to simethicone.
It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
- Conditions
- Infant Colic
- Being tested
- B. breve, B. breve plus L. fermentum, Simethicone 20 MG
- Keywords
- Infant colic, Bifidobacterium breve, Lactobacillus fermentum
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. breveDietary supplement
Bifidobacterium probiotic strain at 1E+08 cfu/day
B. breve plus L. fermentumDietary supplement
Probiotic combination at 2E+08 cfu/day
Simethicone 20 MGDrug
Standard treatment for infant colic
| Study group | Role | What they receive |
|---|---|---|
| B. breve | Experimental | Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water. Receives: Dietary Supplement: B. breve |
| B. breve plus L. fermentum | Experimental | Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water. Receives: Dietary Supplement: B. breve plus L. fermentum |
| Simethicone 20 mg | Active comparator | Control group that will receive simethicone 4 times (10 drops) a day. Receives: Drug: Simethicone 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying time
Crying time in minutes per day
Measured: 4 weeks
Secondary outcomes (3)
Responders to treatment on weeks 1, 2, 3 and 4
Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline
Measured: 4 weeks
Gut microbiota
Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR.
Measured: 4 weeks
Stool carbohydrates
Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4).
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 posted16 Mar 2018
- Study start31 May 2017
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mónica Olivares Martín; PhD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Regional Development Fund, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor-investigator, Mónica Olivares Martín; PhD, Biosearch S.A.
- Investigators
- José Maldonado, MD, PhD, Principal investigator, Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467334
- Sponsor's protocol ID
- P040
- Status last verified
- Jul 2019
- First submitted
- 8 Feb 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic
- ClinicalTrials.gov ID
- NCT03467334
- Acronym / sponsor ID
- P040
- Conditions
- Infant Colic
- Keywords
- Infant colic, Bifidobacterium breve, Lactobacillus fermentum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Mónica Olivares Martín; PhDIndustry (pharma, biotech, devices)
- Collaborators
- European Regional Development Fund, Ministerio de Ciencia e Innovación, Spain
- Study start
- 31 May 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 16 Mar 2018 (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.
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.
Detailed description
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.
The objective of the present study is to compare the effect of B. brevis and B. brevis\L mixture. fermentum with respect to simethicone.
It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B. breve | Experimental | Dietary Supplement: B. breveGroup that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water. |
| B. breve plus L. fermentum | Experimental | Dietary Supplement: B. breve plus L. fermentumGroup that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water. |
| Simethicone 20 mg | Active comparator | Drug: Simethicone 20 MGControl group that will receive simethicone 4 times (10 drops) a day. |
Who may qualify
- Ages
- 3 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants from 3 to 12 weeks of age
- Born at least at week 34
- Birth weight equal to or greater than 2000 grams
- Fulfill the criteria of Rome III
- Informed consent signed by parents or guardians
Key exclusion criteria (5 listed)
- Failure to thrive
- Antibiotic treatment less than 2 weeks before the study or during the study
- Take probiotics as a treatment, different from the one that could contain the powdered infant formula
- Abandon breastfeeding and switch to infant formula
- Failure to comply with the study 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 |
|---|---|---|
| B. breveBifidobacterium probiotic strain at 1E+08 cfu/day | Dietary supplement | B. breve |
| B. breve plus L. fermentumProbiotic combination at 2E+08 cfu/day | Dietary supplement | B. breve plus L. fermentum |
| Simethicone 20 MGStandard treatment for infant colic | Drug | Simethicone 20 mg |
Primary outcome
Crying time
Time frame: 4 weeks
Crying time in minutes per day
3 secondary outcomes
Responders to treatment on weeks 1, 2, 3 and 4
Time frame: 4 weeks
Gut microbiota
Time frame: 4 weeks
Stool carbohydrates
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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. This study is not recruiting at the moment.
José Maldonado, MD, PhD principal investigator
Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B. breve, B. breve plus L. fermentum and Simethicone 20 MG in people with Infant Colic, run by Mónica Olivares Martín; PhD at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 23 Jul 2019. 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 Spain. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crying time (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 23 Jul 2019.