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Effects of oligofructose and inulin in management of chronic nonspecific diarrhoea of childhood – intervention study

Safety and efficacy of a combination of oligofructose and inulin used for chronic nonspecific diarrhoea of childhood when compared with dietary recommendations

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000507583
Enrollment
54
Registered
2015-05-20
Start date
2012-11-07
Completion date
2013-02-22
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

We included patients aged 1 to 5 years old, with at least 5 episodes of diarrhea in the last 6 months fulfilling the criteria of chronic nonspecific diarrhea. The first 31 patients represented the interventional group, named Group A, and the next 23 patients were in the control group (marked as Group B). Group A received a combination of oligofructose and inulin, 4 g/day, divided in 2 daily oral doses for a period of 3 months, and Group B received only dietary recommendations, according to the current guideline. The follow up evaluation included 6 medical visits, the first visit was at the time of inclusion, the second was after 2 weeks, the 3rd visit was after another 2 weeks, the 4th and 5th visits were performed every 30 days and the 6th visit took place after 3 months. The first end point was obtained by comparing clinical efficiency evaluated using gastrointestinal symptoms (vomiting, abdominal pain, constipation) marked with Yes/No answers and counted as episodes per period between visits, number of acute episodes (defined as increased stool frequency with changes of stool consistency) appreciated according to the Bristol Stool Form Scale, where 1 represents hard stools, 7 indicates watery stools, scores lower than 5 indicate normal stool, and the duration of acute episodes is defined as the time from the first loose stool, until at least 12 hours without stool. The second end point consisted of hospitalization (Yes/No answers and the duration of hospitalization according to medical files), use of antibiotics (Yes/No answers were registered), safety and efficiency appreciated by a questionnaire completed by parents in terms of treatment efficiency and acceptance (very good/ good/ moderate were the answers options).

Interventions

Name of intervention: oral supplement of 4 g of inulin enriched with oligofructose (1/1, 2g oligofructose and 2g inulin per day), 1 sachet/day, for 3 months consecutively Strategy used to monitor adherence to the intervention: sachets return

Sponsors

"Grigore Alexandrescu” Children Emergency Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

(1) age 1 to 5 years (2) at least 5 episodes of diarrhoea in the last 6 months (3) normal weight and length for age (4) normal development

Exclusion criteria

comorbidities of any kind abnormal nutritional status acute infections food allergies coeliac disease inflammatory bowel disease gastrointestinal malformation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026