Infantile ColicPROBIOCNCT01887444
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
A study testing Lactobacillus reuteri DSM17938 probiotic in people with Infantile Colic, run by BioGaia AB at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. Read more about this study
- Who is it for?
- Ages 29 days to 3 months
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Lactobacillus reuteri DSM17938 probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- 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 29 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Exclusively breastfed Infants
- Infant aged of 29 days to 3 months
- With a diagnosis of infantile colic as defined by the Rome III criteria
- Birth at term and eutrophic (weight, height, head circumference)
- Apgar score> 7 at 5 minutes
- Consent to the study signed by the two parents.
- Availability during the study period
Who cannot join
- Associated severe chronic disease
- Acute infectious disease
- Personal or family first degree history of allergy to milk proteins
- Several infants of the same family from a multiple pregnancy
- Infants who received antibiotics one week prior to randomization
- Infants who received probiotics one week prior to randomization
Show all 11Show fewer
- Mother who received antibiotics 1 week before randomization
- Regular consumption of probiotics by the mother 1 week before randomization
- Infants-included in another clinical study
- Lack of insurance coverage by the french social security
- Non exclusively breastfed infants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.
Read the detailed description
NOTE: The study never started.
- Conditions
- Infantile Colic
- Being tested
- Lactobacillus reuteri DSM17938 probiotic, Placebo
- Keywords
- Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM17938 probioticDietary supplement
Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.
PlaceboOther
Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reteuri | Experimental | Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days Receives: Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic |
| Placebo | Placebo comparator | Other: Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.
Measured: day 7
Secondary outcomes (1)
The responders rates at D14 and D21 in the probiotic group compared to the placebo group.
Measured: Day 14 and day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionSep 2014
Why it stopped: Never started
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRC CHI Creteil France, Association Clinique Thérapeutique Infantile du val de Marne, Hopital Universitaire Robert-Debre
- Responsible party
- Sponsor
- Investigators
- Marc Bellaiche, MD, Principal investigator, Hopital Universitaire Robert-Debre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887444
- Sponsor's protocol ID
- 2013-A00163-42
- Acronym
- PROBIOC
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2013
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
- ClinicalTrials.gov ID
- NCT01887444
- Acronym / sponsor ID
- PROBIOC / 2013-A00163-42
- Conditions
- Infantile Colic
- Keywords
- Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- CRC CHI Creteil France, Association Clinique Thérapeutique Infantile du val de Marne, Hopital Universitaire Robert-Debre
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- 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 purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.
Detailed description
NOTE: The study never started.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reteuri | Experimental | Dietary Supplement: Lactobacillus reuteri DSM17938 probioticDietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days |
| Placebo | Placebo comparator | Other: PlaceboOther: Placebo |
Who may qualify
- Ages
- 29 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Exclusively breastfed Infants
- Infant aged of 29 days to 3 months
- With a diagnosis of infantile colic as defined by the Rome III criteria
- Birth at term and eutrophic (weight, height, head circumference)
- Apgar score> 7 at 5 minutes
Key exclusion criteria (11 listed)
- Associated severe chronic disease
- Acute infectious disease
- Personal or family first degree history of allergy to milk proteins
- Several infants of the same family from a multiple pregnancy
- Infants who received antibiotics one week prior to randomization
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 |
|---|---|---|
| Lactobacillus reuteri DSM17938 probioticDrops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion. | Dietary supplement | Lactobacillus reteuri |
| PlaceboDrops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics. | Other | Placebo |
Primary outcome
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.
Time frame: day 7
1 secondary outcome
The responders rates at D14 and D21 in the probiotic group compared to the placebo group.
Time frame: Day 14 and day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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.
Marc Bellaiche, MD principal investigator
Hopital Universitaire Robert-Debre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri DSM17938 probiotic in people with Infantile Colic, run by BioGaia AB at 1 site 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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 4 Feb 2021. 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes. (time frame: day 7). 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 4 Feb 2021.