Back to resultsAssessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
Primary Purpose
Dysbiosis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
L. reuteri
B. longum and P. Pentosaceus
Sponsored by
About this trial
This is an interventional prevention trial for Dysbiosis
Eligibility Criteria
Inclusion Criteria:
- Healthy infants in their first week of life
- Infants with adequate weight according to the gestational age.
- Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
- Gestational birth equal or greater than 37 weeks.
- Exclusive or almost exclusive breastfeeding - understanding almost exclusive the one in which there is a maximum of one formula dose per day - or mixt breastfeeding, the one in which there are more than one formula dose per day.
Exclusion Criteria:
- Infants with smoker mother during pregnancy and after delivery.
- Infants whose parents cannot follow the study requirements
- Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
- Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
- Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
- Infants who ingest special formulas as extensively hydrolysed formulas.
- Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
- Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
- Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.
Sites / Locations
- Neonatal Unit, Hospital Clinic-MaternitatRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
L. reuteri
B. longum and P. Pentosaceus
Arm Description
Group that will receive L. reuteri one dose per day in an oral suspension Intervention: Dietary Supplement: L. reuteri
Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension. Intervention: Dietary Supplement: B. longum and P. Pentosaceus
Outcomes
Primary Outcome Measures
Metagenomic analysis of gut microbiota
The achievement of a microbiota dominated by Bacteroides, Lactobacillus and Bifidobacterium, along with a decrease in Enterobacteria after 4 weeks of probiotic treatment. Faecal sampleswill be collected at baseline and 1 month after probiotic treatment.
Secondary Outcome Measures
Number of regurgitations by questionnaire included in patients' diary
Number of regurgitations will be documented by the parents each week for 3 months in patients diary
Number of constipation episodes by questionnaire included in patients' diary
Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary
Number of infant colic episodes by questionnaire included in patients' diary
Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary
Metagenomic analysis of total gut microbiota
This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment.
Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary
Number of respiratory, gastrointestinal infections and use of medication episodes will be documented by the parents each week for 3 months in patient's diary
Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)
Anxiety and depression levels of the father and mother will be evaluated at baseline and 3 months after probiotic treatment through the Hospital Anxiety and Depression Scale (HADS) questionnaire will be.
Odd questions (assess anxiety). Even questions (assess depression). Score less than or equal to 7 = no case. 8-10 = doubtful case Score equal to or greater than 11 = case
Extra visits to paediatrician/emergency by questionnaire included in the patient's diary
Number of paediatric visits and / or emergency access will be documented each week in the patient's diary during the 3 months of treatment
Number of Participants With Treatment-Related Adverse Events
Adverse events will be documented weekly in the patient's diary during the 3 months of treatment.
Levels of IgA in faeces
changes in IgA in faeces from baseline to 1 month of treatment
Weight evolution by the paedatrician in study visits
Changes on baby's body weight from baseline to 3 months of probiotic treatment
Full Information
NCT ID
NCT04304014
First Posted
March 4, 2020
Last Updated
May 15, 2023
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT04304014
Brief Title
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
Official Title
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
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
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day.
Detailed Description
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.
L. reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbiosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
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
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
L. reuteri
Arm Type
Experimental
Arm Description
Group that will receive L. reuteri one dose per day in an oral suspension
Intervention: Dietary Supplement: L. reuteri
Arm Title
B. longum and P. Pentosaceus
Arm Type
Experimental
Arm Description
Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension.
Intervention: Dietary Supplement: B. longum and P. Pentosaceus
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri
Intervention Description
(10^8 CFU) once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
B. longum and P. Pentosaceus
Intervention Description
(10^9 CFU) once a day
Primary Outcome Measure Information:
Title
Metagenomic analysis of gut microbiota
Description
The achievement of a microbiota dominated by Bacteroides, Lactobacillus and Bifidobacterium, along with a decrease in Enterobacteria after 4 weeks of probiotic treatment. Faecal sampleswill be collected at baseline and 1 month after probiotic treatment.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of regurgitations by questionnaire included in patients' diary
Description
Number of regurgitations will be documented by the parents each week for 3 months in patients diary
Time Frame
3 months
Title
Number of constipation episodes by questionnaire included in patients' diary
Description
Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary
Time Frame
3 months
Title
Number of infant colic episodes by questionnaire included in patients' diary
Description
Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary
Time Frame
3 months
Title
Metagenomic analysis of total gut microbiota
Description
This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment.
Time Frame
1 month
Title
Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary
Description
Number of respiratory, gastrointestinal infections and use of medication episodes will be documented by the parents each week for 3 months in patient's diary
Time Frame
3 months
Title
Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)
Description
Anxiety and depression levels of the father and mother will be evaluated at baseline and 3 months after probiotic treatment through the Hospital Anxiety and Depression Scale (HADS) questionnaire will be.
Odd questions (assess anxiety). Even questions (assess depression). Score less than or equal to 7 = no case. 8-10 = doubtful case Score equal to or greater than 11 = case
Time Frame
3 months
Title
Extra visits to paediatrician/emergency by questionnaire included in the patient's diary
Description
Number of paediatric visits and / or emergency access will be documented each week in the patient's diary during the 3 months of treatment
Time Frame
3 months
Title
Number of Participants With Treatment-Related Adverse Events
Description
Adverse events will be documented weekly in the patient's diary during the 3 months of treatment.
Time Frame
3 months
Title
Levels of IgA in faeces
Description
changes in IgA in faeces from baseline to 1 month of treatment
Time Frame
1 month
Title
Weight evolution by the paedatrician in study visits
Description
Changes on baby's body weight from baseline to 3 months of probiotic treatment
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Week
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy infants in their first week of life
Infants with adequate weight according to the gestational age.
Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
Gestational birth equal or greater than 37 weeks.
Exclusive or almost exclusive breastfeeding - understanding almost exclusive the one in which there is a maximum of one formula dose per day - or mixt breastfeeding, the one in which there are more than one formula dose per day.
Exclusion Criteria:
Infants with smoker mother during pregnancy and after delivery.
Infants whose parents cannot follow the study requirements
Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
Infants who ingest special formulas as extensively hydrolysed formulas.
Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
García-Algar Óscar, PhD
Phone
0034 932275607
Email
ogarciaa@clinic.cat
Facility Information:
Facility Name
Neonatal Unit, Hospital Clinic-Maternitat
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Garcia-Algar, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
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