Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 8 for:    lactobacillus fermentum

Infant Colic Treatment With Probiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467334
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
European Regional Development Fund
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Mónica Olivares Martín; PhD, Biosearch S.A.

Brief 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. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

Condition or disease Intervention/treatment Phase
Infant Colic Dietary Supplement: B. breve Dietary Supplement: B. breve plus L. fermentum Drug: Simethicone 20 MG Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone

Arm Intervention/treatment
Experimental: B. breve
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.
Dietary Supplement: B. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day

Experimental: B. breve plus L. fermentum
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.
Dietary Supplement: B. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day

Active Comparator: Simethicone 20 mg
Control group that will receive simethicone 4 times (10 drops) a day.
Drug: Simethicone 20 MG
Standard treatment for infant colic




Primary Outcome Measures :
  1. Crying time [ Time Frame: 4 weeks ]
    Crying time in minutes per day


Secondary Outcome Measures :
  1. Responders to treatment on weeks 1, 2, 3 and 4 [ Time Frame: 4 weeks ]
    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

  2. Gut microbiota [ Time Frame: 4 weeks ]
    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.

  3. Stool carbohydrates [ Time Frame: 4 weeks ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467334


Locations
Layout table for location information
Spain
Servicio Andaluz de Salud
Granada, Spain, 10012
Sponsors and Collaborators
Mónica Olivares Martín; PhD
European Regional Development Fund
Ministerio de Ciencia e Innovación, Spain
Investigators
Layout table for investigator information
Principal Investigator: José Maldonado, MD, PhD Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)
Layout table for additonal information
Responsible Party: Mónica Olivares Martín; PhD, Head of the R & D Department, Biosearch S.A.
ClinicalTrials.gov Identifier: NCT03467334    
Other Study ID Numbers: P040
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mónica Olivares Martín; PhD, Biosearch S.A.:
Infant colic
Bifidobacterium breve
Lactobacillus fermentum
Additional relevant MeSH terms:
Layout table for MeSH terms
Colic
Infant, Newborn, Diseases
Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents