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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000507583
• Date of registration: 20/05/2015
• Prospective Registration: No
• Primary sponsor: "Grigore Alexandrescu” Children Emergency Hospital
• Public title: Effects of oligofructose and inulin in management of chronic nonspecific diarrhoea of childhood – intervention study
• Scientific title: Safety and efficacy of a combination of oligofructose and inulin used for chronic nonspecific diarrhoea of childhood when compared with dietary recommendations
• Date of first enrolment: 07/11/2012
• Target sample size: 54
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000507583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Romania

Contacts

• Name: Dr Tincu Iulia Florentina

• Name: Dr Becheanu Cristina Adriana

Key inclusion & exclusion criteria

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


Age minimum: 1 Years
Age maximum: 5 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Chronic nonspecific diarrhoea of childhood;
Chronic nonspecific diarrhoea of childhood

Intervention(s)

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

Primary Outcome(s)

Primary Outcome 1: duration of acute episodes in chronic nonspecific diarrhoea
acute episode: 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
duration of acute episodes: is defined as the time from the first loose stool, until at least 12 hours without stool.[Timepoint: during intervention and 3 months after intervention stopped
]

Primary Outcome 2: severity of acute episode in chronic nonspecific diarrhoea evaluated by association of symptoms: vomiting, abdominal pain, constipation; this was marked with Yes/No answers and counted as episodes per period between visits[Timepoint: during intervention and 3 months after intervention stoped ]

Secondary Outcome(s)

hospitalization : yes/no answers, duration of hospitalization in days[during the follow up procedure]

use of antibiotics for any reasons, acute infections during the follow up procedure; the first one refers to intestinal infections and the second one refers to use of antibiotics in general[during intervention and 3 months after intervention stoped]

Need for antibiotic use for acute infectious intestinal episodes[Timepoint: during intervention and 3months after intervention stoped ]

safety and efficiency of the supplement appreciated by a questionnaire completed by parents in terms of treatment efficiency and acceptance (very good/ good/ moderate were the answers options).[during intervention and 3 months after intervention stoped]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

"Grigore Alexandrescu” Children Emergency Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of : "Grigore Alexandrescu” Children Emergency Hospital