ColicPhase 4NCT01067027
Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
A Phase 4 study testing Lactobacillus reuteri in people with Colic, run by Children's Investigational Research Program, LLC at 1 site in United States.
Trial summary
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic. Read more about this study
- Who is it for?
- Ages 14 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Colic
- What is being tested?
- Lactobacillus reuteri
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2012
- Phase
- Phase 4
- 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 14 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ifants aged between 14 and 60 days
- Breast fed, exclusively during length of trial
- Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
- Debut of colic symptoms 6+/-1 days before randomization
- Gestational age between 37 and 42 weeks
- Apgar score higher than 7 at 5 minutes
Show all 9Show fewer
- Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
- Written informed consent from one or both parents
- Stated availability throughout the study period
Who cannot join
- Major chronic disease
- Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
- Administration of anitbiotics the week before randomization
- Administration of probiotics the week before randomization
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Investigational Research Program
Bentonville, Arkansas, 72712
Misty R Ross, MA, 479-254-6772 ext. 21, mross@chirpresearch.com
Tonya D Hogue, Coordinator, 479-254-6772 ext. 22, thogue@chirpresearch.com
About this study
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
- Conditions
- Colic
- Being tested
- Lactobacillus reuteri
- Keywords
- Colic, Colic in Breast-fed Infants
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
5 drops of study product 30 minutes before feeding.
What is being measured
The primary outcome is the main question the study is designed to answer.
* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
Measured: 7, 14 and 21 days
Secondary outcomes (1)
Number of responders versus non-responders with L. reuteri versus placebo at end of the study.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Investigational Research Program, LLC
- Sponsor type
- University, hospital or other
- Investigators
- Bryan M Harvey, M.D., Principal investigator, Children's Investigational Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067027
- Sponsor's protocol ID
- Colic001
- Status last verified
- Jun 2011
- First submitted
- 9 Feb 2010
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
- ClinicalTrials.gov ID
- NCT01067027
- Acronym / sponsor ID
- Colic001
- Conditions
- Colic
- Keywords
- Colic, Colic in Breast-fed Infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Investigational Research Program, LLCUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 11 Feb 2010 (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.
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 14 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Ifants aged between 14 and 60 days
- Breast fed, exclusively during length of trial
- Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
- Debut of colic symptoms 6+/-1 days before randomization
- Gestational age between 37 and 42 weeks
Key exclusion criteria (5 listed)
- Major chronic disease
- Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
- Administration of anitbiotics the week before randomization
- Administration of probiotics the week before randomization
- Participation in other clinical trials
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 reuteri5 drops of study product 30 minutes before feeding. | Dietary supplement | – |
Primary outcome
* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
Time frame: 7, 14 and 21 days
1 secondary outcome
Number of responders versus non-responders with L. reuteri versus placebo at end of the study.
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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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.
Bryan M Harvey, M.D. principal investigator
Children's Investigational Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus reuteri in people with Colic, run by Children's Investigational Research Program, LLC at 1 site in United States.
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 9 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: status not confirmed, as of the sponsor's last update on 29 Jun 2011. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Misty R Ross, MA (479-254-6772 ext. 21, mross@chirpresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
* Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents. (time frame: 7, 14 and 21 days). 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 Jun 2011.