Colic, InfantileNCT03106285
Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
A study testing Lactobacillus reuteri DSM17938 in people with Colic, Infantile, run by BioGaia AB at 1 site in Indonesia.
Trial summary
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Colic, Infantile
- What is being tested?
- Lactobacillus reuteri DSM17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Apr 2017to 1 Jul 2019
- 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- otherwise healthy infants
- Infantile colic according to Roe IV criteria
- Full term infants
- Birth weight 2500 - 4000g
- Exclusively breast milk or partially breastfed
- Mothers last education degree is Senior high school
Who cannot join
- Clinically suspected allergy
- Consumption of probiotics, antibiotics, PPI
- Failure to thrive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
This study aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Read the detailed description
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.
Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
- Conditions
- Colic, Infantile
- Being tested
- Lactobacillus reuteri DSM17938, Placebo
- 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 DSM17938Dietary supplement
5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938
PlaceboDietary supplement
5 drops of placebo drops
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri DSM17938 | Experimental | Oil drops Receives: Dietary Supplement: Lactobacillus reuteri DSM17938 |
| Placebo | Placebo comparator | Oils drops Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Measured: day 7
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Measured: Day 14
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Measured: Day 21
Daily average of crying time with L reuteri vs placebo
Daily crying diary
Measured: Day 28
Secondary outcomes (5)
Number of responder vs non-responders
Daily crying
Measured: baseline, day 7, 14, 21, 28
Reduction of daily average crying time
Daily crying
Measured: baseline, day 7, 14, 21, 28
Parents perception of colic severity (Diary)
Diary
Measured: baseline, day 7, 14, 21, 28
Parents/Family quality of life (Diary)
Diary
Measured: baseline, day 7, 14, 21, 28
Parental satisfactory (Diary)
Diary
Measured: baseline, day 7, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start14 Apr 2017
- Primary completion1 May 2019
- Study completion1 Jul 2019
Why it stopped: Cannot perform the study due to practical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Badriul Hegar, MD, PhD, Principal investigator, RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106285
- Sponsor's protocol ID
- CSUB0130
- Status last verified
- May 2022
- First submitted
- 24 Mar 2017
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lactobacillus Reuteri DSM17938 Supplementation on Crying Time in Infantile Colic
- ClinicalTrials.gov ID
- NCT03106285
- Acronym / sponsor ID
- CSUB0130
- Conditions
- Colic, Infantile
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cannot perform the study due to practical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 10 Apr 2017 (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 aims to investigate the effectiveness of Lactobacillus reuteri DSM17938 supplementation on infantile colic in Indonesian infants.
Detailed description
Infantile colic is a problem faced by many parents and caregivers. There is no evidence that medications does help in this situation. The etiology of infantile colic is still unknown.
Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri DSM17938 | Experimental | Dietary Supplement: Lactobacillus reuteri DSM17938Oil drops |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOils drops |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- otherwise healthy infants
- Infantile colic according to Roe IV criteria
- Full term infants
- Birth weight 2500 - 4000g
- Exclusively breast milk or partially breastfed
Key exclusion criteria (3 listed)
- Clinically suspected allergy
- Consumption of probiotics, antibiotics, PPI
- Failure to thrive
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 DSM179385 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938 | Dietary supplement | Lactobacillus reuteri DSM17938 |
| Placebo5 drops of placebo drops | Dietary supplement | Placebo |
Primary outcome
Daily average of crying time with L reuteri vs placebo
Time frame: day 7
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Time frame: Day 14
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Time frame: Day 21
Daily crying diary
Daily average of crying time with L reuteri vs placebo
Time frame: Day 28
Daily crying diary
5 secondary outcomes
Number of responder vs non-responders
Time frame: baseline, day 7, 14, 21, 28
Reduction of daily average crying time
Time frame: baseline, day 7, 14, 21, 28
Parents perception of colic severity (Diary)
Time frame: baseline, day 7, 14, 21, 28
Parents/Family quality of life (Diary)
Time frame: baseline, day 7, 14, 21, 28
Parental satisfactory (Diary)
Time frame: baseline, day 7, 14, 21, 28
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 5 May 2022.
- 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. This study is not recruiting at the moment.
Badriul Hegar, MD, PhD principal investigator
RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
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 in people with Colic, Infantile, run by BioGaia AB at 1 site in Indonesia.
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 6 inclusion and 3 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 5 May 2022. 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 Indonesia. 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?
Daily average of crying time with L reuteri vs placebo (time frame: day 7). The study lists 4 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 5 May 2022.