Other Clinical Trial - Prevalence of FGIDs & Probiotics Study

Status Not yet recruiting

Clinical Trial Summary

This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants.

Clinical Trial Description

This is a randomized controlled trial study about the the efficacy of Lactobacillus reuteri DSM 1987 to prevent FGIDs in healthy infants and the effect to gut microbiota diversity. The incidence of FGIDs in Thai infant using Thai version of ROME IV questionnaire (authorized by Rome Foundation) for infant and toddler and the associated factors of FGIDs also evaluate. Population: target and control populations are the healthy infants born at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, and can come to follow up at the hospital at 1, 2, 4, and 12 months of age Inclusion criteria 1. Healthy and term (GA 37-41 weeks) infants 2. Appropriate weight for age 3. APGAR score more than 8 at 10 minutes of life 4. Normal physical examination 5. Mothers have no previous probiotics use Methodology - Participants were double-blinded randomized using computer generation in block of four - Target population were received Limosilactobacillus reuteri DSM 17938 5 drops (0.185 mL) per day for 60 days - Control population were received mixture of sunflower oil and MCT oil 5 drop (0.185 mL) per day for 60 days - There were 5 visits at birth, 1, 2, 4, 12 months of life: the demographic data/Rome IV questionnaire for FGIDs in infant and associated factors with FGIDs record, physical examination and stool collection - Research assistance will telephone to them to take the Rome IV questionnaire for FGIDs at 3, 6, 9 months of life Biological specimen collection Stool will be collected by rectal stimulation in each visit. The amount of >5 gm stool will be preserved in DNA and kept at -80 °C. All stool specimen will be processed the DNA extraction (DNA > 40 microlitre with concentration >50 ng/L). The DNA extraction for further amplification 16S rRNA using Illumina. The rest of the specimen will be kept up to 10 years for further evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06309199
Study type	Interventional
Source	Chulalongkorn University
Contact	Palittiya Sintusek, PhD
Phone	+66818288082
Email	palittiya.s@chula.ac.th
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	February 2026

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05936112` - Quantification of Fecal Calprotectin Concentration Difference Between Infants Aged Under 4 Months Old Suffering From Functional Gastrointestinal Disorders (FGID) and Infants Aged Under 4 Months Old Free From Disorders : a Transversal Case-control Monocentric Study	N/A
Completed	`NCT02565355` - Targeted Food Elimination for Treatment of Functional Gastrointestinal Diseases in Children	N/A
Completed	`NCT02657668` - Emotion Focused Therapy in Irritable Bowel Syndrome Patients	N/A
Completed	`NCT02731664` - GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans	Phase 1
Recruiting	`NCT06205446` - Application of Diaphragmatic Breathing in Patients With Disorders of Gut-brain Interaction	N/A
Recruiting	`NCT05718960` - Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia	N/A
Terminated	`NCT04247100` - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders	N/A
Recruiting	`NCT03625674` - Impact of Stigma on Compliance to Medication in Functional Dyspepsia	N/A
Completed	`NCT03252743` - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.	N/A
Recruiting	`NCT05832528` - Low FODMAP Diet in FD (PDS)	N/A
Completed	`NCT02936713` - Effect of Controlled Diet Combined With a Fermented Milk Product on Gas-related Symptoms	N/A
Terminated	`NCT01712412` - Phase 2a Study of IW-9179 to Treat Functional Dyspepsia	Phase 2
Completed	`NCT00564525` - Study of Medication for Functional Abdominal Pain in Children	Phase 4
Recruiting	`NCT05987813` - Transcutaneous Electric Nerve Stimulation (TENS) for Vagal Modulation	N/A
Completed	`NCT04155801` - A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances	N/A
Recruiting	`NCT05880199` - BSGM to Evaluate Patients With GI Symptoms
Recruiting	`NCT04625881` - Effects of an Apple Derived Fibre Supplement on Constipation	Phase 3
Completed	`NCT03608735` - Prevalence of Functional Gastrointestinal Disorders (FGIDs), Related Signs and Symptoms in Infants/Toddlers in Thailand
Recruiting	`NCT04773158` - Systematic Pediatric Assessment of Rome Criteria	N/A
Completed	`NCT02306369` - Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prevalence of FGIDs and Probiotics Study — PROOF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms