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To compare the beneficial effects of two different prebiotics on gut problems in Autism spectrum disorder children

Comparison between Inulin and Human Milk Oligosacchrides in managing Gut Issues in Autistic Children: A randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048212
Enrollment
60
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: Human milk Oligosaccharides (HMO): Pure HMO for kids Powder containing 2â??Fucosyllactose 800mg per serving and Lacto-N-neotetraose 200mg per serving. Serving size -1/2 scoop (1.0 gm).

Sponsors

Gigglesclinics
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed cases of ASD as per DSM 5 and CARS(childhood autistic rating ) scale with gut related problems as per ROme 3 modified parent questionnaire who were on normal diet

Exclusion criteria

Exclusion criteria: Cases of ASD cases were exlcluded who were not having gut related problems as per Rome 3 questionnaire and were on elimination diets like gluetin free and caesin free(GFCF)

Design outcomes

Primary

MeasureTime frame
Changes in gastrointestinal (GI)symptoms symptoms as measured by modified ROME3 questionnaire for FGID in children using different variables like diarrhoea,constipation,abdominal pain , vomiting and Bloating. scores were given as 0- never , score1- 1-3 times in a month , score2- once a week , score3- several times in a week , score 4- every day. higher the score is , more is the severityTimepoint: baseline and at 3 months

Secondary

MeasureTime frame
Changes in gastrointestinal (GI)symptoms symptoms as measured by modified ROME3 questionnaire for FGID in children using different variables like diarrhoea,constipation,abdominal pain , vomiting and Bloating. scores were given as 0- never , score1- 1-3 times in a month , score2- once a week , score3- several times in a week , score 4- every day. higher the score is , more is the severityTimepoint: at 6 months

Countries

India

Contacts

Public ContactDr Lalit Mittal

Gigglesclinics

gigglesclinics@gmail.com9818403871

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026