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Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Children's Investigational Research Program, LLC.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Children's Investigational Research Program, LLC
Information provided by:
Children's Investigational Research Program, LLC
ClinicalTrials.gov Identifier:
NCT01067027
First received: February 9, 2010
Last updated: June 28, 2011
Last verified: June 2011
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Purpose
It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.
| Condition | Intervention | Phase |
|---|---|---|
| Colic | Dietary Supplement: Lactobacillus reuteri | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri |
Resource links provided by NLM:
MedlinePlus related topics:
Dietary Supplements
Drug Information available for:
Lactobacillus
U.S. FDA Resources
Further study details as provided by Children's Investigational Research Program, LLC:
Primary Outcome Measures:
- * 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 ]
Secondary Outcome Measures:
- Number of responders versus non-responders with L. reuteri versus placebo at end of the study. [ Time Frame: 21 days ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Dietary Supplement: Lactobacillus reuteri
5 drops of study product 30 minutes before feeding.
Eligibility| Ages Eligible for Study: | up to 60 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067027
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067027
Contacts
| Contact: Misty R Ross, MA | 479-254-6772 ext 21 | mross@chirpresearch.com |
Locations
| United States, Arkansas | |
| Children's Investigational Research Program | Recruiting |
| Bentonville, Arkansas, United States, 72712 | |
| Contact: Misty R Ross, MA 479-254-6772 ext 21 mross@chirpresearch.com | |
| Contact: Tonya D Hogue, Coordinator 479-254-6772 ext 22 thogue@chirpresearch.com | |
Sponsors and Collaborators
Children's Investigational Research Program, LLC
Investigators
| Principal Investigator: | Bryan M Harvey, M.D. | Children's Investigational Research Program |
More Information
| Responsible Party: | Bryan M. Harvey, M.D., Children's Investigational Research Program |
| ClinicalTrials.gov Identifier: | NCT01067027 History of Changes |
| Other Study ID Numbers: |
Colic001 |
| Study First Received: | February 9, 2010 |
| Last Updated: | June 28, 2011 |
Keywords provided by Children's Investigational Research Program, LLC:
|
Colic Colic in Breast-fed Infants |
Additional relevant MeSH terms:
|
Colic Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on July 14, 2017