Management of Infant Digestive Disorders and Quality of Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-28

Study Completion Date

2021-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics Supplementation in Premature Infants

NCT01379417

Prematurity

COMPLETED NA

Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

NCT06488274

Functional Gastrointestinal Disorders

RECRUITING NA

Gut Bacteria and Brain of the Baby

NCT04432636

Premature

RECRUITING NA

Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

NCT04962594

Healthy Infants

COMPLETED NA

Study in Unsettled Infants Experiencing Feeding Intolerance

NCT02021058

Feeding Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic, following nutritional management of these disorders by a preparation for thickened infants, reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of life is assessed using the QUALIN questionnaire

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Nutrition Disorders Gastrointestinal Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

regurgitation

45 infants aged 0 to 5 months suffering from regurgitation

Management of Infant Digestive Disorders and Quality of Life

Intervention Type OTHER

The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.

colic

45 infants aged 0 to 5 months suffering from colic

Management of Infant Digestive Disorders and Quality of Life

Intervention Type OTHER

The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Management of Infant Digestive Disorders and Quality of Life

The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Full-term infants (\> 37 weeks gestation and \<42 weeks gestation), less than 4 months of age at recruitment

* Infants with regurgitation and / or colic defined according to Rome IV criteria
* Non-breastfed infants
* Parents who understand and speak French fluently
* Parents agreeing to send their email address and having a computer tool (computer, tablet or smartphone) allowing them to complete the QoL questionnaires and the satisfaction questionnaire
* Parents having understood the protocol and the information given and having given the participation agreement including their acceptance to return for consultation with the same doctor after a period of 30 days.

Exclusion Criteria

Infant born prematurely (\<37 weeks)

• Intercurrent pathology other than a functional intestinal disorder which can by themselves cause, directly or as a result of treatments, a functional intestinal disorder: Study Management of infant digestive disorders and Quality of life

* Food allergy
* Digestive pathology (Gastroenteritis, celiac disease, high or low digestive malformations….)
* Heart failure, cyanogenic heart disease
* Chronic respiratory diseases (bronchopulmonary dysplasia, malformations, respiratory failure)
* Neurological pathologies (Cerebral palsy, intracranial hypertension, convulsive state)
* Congenital metabolic pathologies
* Genetic diseases
* Kidney malformations, Vesicoureteral reflux, Kidney failure.
* Drug treatment in progress and which will be continued during the study, other than vitamins (D, K, ...)
* Partial or total breastfeeding
* Infants already fed:
* with a hypoallergenic formula (HA)
* or with a high hydrolyzate of cow's milk proteins or formula based on rice protein hydrolyzate
* Growth retardation (weight and or height less than or equal to - 2 DS) or break in the weight curve (no weight gain or weight loss in the past month) Prescription of drugs or food supplements other than vitamins at the end of the visit

Minimum Eligible Age

1 Week

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes