search
Back to results

Prospective Study to Determine the Factors Influencing Infant Colic

Primary Purpose

Infant Colic

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lactoflora colicare
Reuteri gotas
Sponsored by
AB Biotics, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infant Colic focused on measuring Infant colic, probiotic

Eligibility Criteria

2 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants from 2 to 12 weeks of age
  • Infants diagnosed with infant colic following Roma IV criteria for clinical research
  • Gestational age greater or equal to 37 weeks
  • Birth weight greater than 2100 g
  • Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.

Exclusion Criteria:

  • Infants that are fed with solid food.
  • Infants whose parents can not appropriately follow the requirements of the study.
  • Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
  • Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
  • Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
  • Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.

Sites / Locations

  • Hospital Medica Sur, room 108, tower 2Recruiting
  • University Hospital Santa Lucía
  • HM Hospitals
  • Hm Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lactoflora colicare

Reuteri gotas

Arm Description

Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Outcomes

Primary Outcome Measures

Duration of crying and fussing
Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.

Secondary Outcome Measures

Number of regurgitations
Change in daily number of regurgitations
Bowel movements
Change in daily number of bowel movements
Food intake
Frequency of food intake
Parent's anxiety and depression
Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Fecal microbiome
Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis
Fecal calprotectin
Change on calprotectin in feces
Adverse events
Frequency of adverse events reported on dairy report form after randomization and until day 21

Full Information

First Posted
February 28, 2022
Last Updated
October 16, 2023
Sponsor
AB Biotics, SA
search

1. Study Identification

Unique Protocol Identification Number
NCT05271747
Brief Title
Prospective Study to Determine the Factors Influencing Infant Colic
Official Title
Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Biotics, SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
Detailed Description
Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula). Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events. Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Colic
Keywords
Infant colic, probiotic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, multicentric, single-blind trial in 100 infants between 2 and 12 weeks of age diagnosed with infant colic, who will be allocated to receive one of the two comercialized probiotic products B. Longum and P. Pentosaceus (branch one) or L. Reuteri (branch two) for 21 days
Masking
Investigator
Masking Description
Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactoflora colicare
Arm Type
Active Comparator
Arm Description
Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority
Arm Title
Reuteri gotas
Arm Type
Active Comparator
Arm Description
Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactoflora colicare
Intervention Description
Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 for 21 days, 5 drops/day preferably during the first intake of milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Reuteri gotas
Intervention Description
Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
Primary Outcome Measure Information:
Title
Duration of crying and fussing
Description
Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Number of regurgitations
Description
Change in daily number of regurgitations
Time Frame
21 days
Title
Bowel movements
Description
Change in daily number of bowel movements
Time Frame
21 days
Title
Food intake
Description
Frequency of food intake
Time Frame
21 days
Title
Parent's anxiety and depression
Description
Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Time Frame
baseline, day 21
Title
Fecal microbiome
Description
Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis
Time Frame
baseline, day 21
Title
Fecal calprotectin
Description
Change on calprotectin in feces
Time Frame
baseline, day 21
Title
Adverse events
Description
Frequency of adverse events reported on dairy report form after randomization and until day 21
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants from 2 to 12 weeks of age Infants diagnosed with infant colic following Roma IV criteria for clinical research Gestational age greater or equal to 37 weeks Birth weight greater than 2100 g Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk. Exclusion Criteria: Infants that are fed with solid food. Infants whose parents can not appropriately follow the requirements of the study. Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study. Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study. Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone. Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meritxell Aguiló García, PhD
Phone
+34 93 592 97 97
Email
aguilo@ab-biotics.com
Facility Information:
Facility Name
Hospital Medica Sur, room 108, tower 2
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Andrade, MD
Phone
+525535209755
Email
dianamandrade@yahoo.com
Facility Name
University Hospital Santa Lucía
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Individual Site Status
Completed
Facility Name
HM Hospitals
City
Barcelona
Country
Spain
Individual Site Status
Completed
Facility Name
Hm Hospitals
City
Madrid
Country
Spain
Individual Site Status
Completed

12. IPD Sharing Statement

Citations:
PubMed Identifier
27147121
Citation
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
Results Reference
background

Learn more about this trial

Prospective Study to Determine the Factors Influencing Infant Colic

We'll reach out to this number within 24 hrs