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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2018 |
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Main ID: |
ISRCTN12919460 |
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Date of registration:
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14/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study to evaluate the efficacy of probiotic product Bio-Kult Infantis as concomitant treatment of acute infectious diarrhoea in children
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Scientific title:
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Randomized, 2 arm, parallel, double-blind, placebo-controlled clinical study to evaluate the efficacy of probiotic product Bio-Kult Infantis as adjuvant therapy in treatment of acute gastroenteritis in children |
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Date of first enrolment:
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15/07/2016 |
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Target sample size:
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186 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12919460 |
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Study type:
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Interventional |
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Study design:
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Paediatric multi-centre randomized double-blind 2 arm parallel placebo-controlled clinical study (Treatment)
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Phase:
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Countries of recruitment
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Croatia
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Slovenia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mojca
Fir |
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Address:
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Vizera d.o.o.
Vojkova 4
1000
Ljubljana
Slovenia |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patient Informed Consent (PIC) form signed by parent or legal guardian
2. Aged between 6 months and 6 years (up to the age of 5 years and 11 months) at the time of the signature of PIC
3. Confirmed acute diarrhoea according to WHO (at least 3 loose or watery stools within last 24h), which lasted less than 2 days (< 48 h) prior to signature of PIC
4. Diagnosed with acute gastroenteritis with evidence of dehydration (evaluated according to CDS) and in need of rehydration therapy (oral or IV)
5. Only patient treated in an out-patient setting (i.e. managed in an A+E department without subsequent hospitalization) is eligible; if it is decided that the patient needs to be hospitalized, he or she should not be included in the study
Exclusion criteria: 1. Patient diagnosed with gastroenteritis, but it is determined that they don’t need rehydration treatment (Score 0 according to CDS)
2. Patient who received antibiotic treatment within the last two months prior to onset of gastroenteritis
3. Patient who was taking probiotic supplements, dairy product with high bacterial count, such as Actimel or Yakult, or milk formula with probiotics, in the last month prior to onset of gastroenteritis (consumption of normal yoghurts is acceptable)
4. Patient who has to be hospitalized
5. Patient who is exclusively breastfed
6. Patient with diabetes
7. Immuno-compromised patient or patient with other severe chronic disorders that might influence the outcome of study therapy (as evaluated by Investigator)
8. Patient with oedema
9. Malnutrition (< 3% EBW; under the 3rd percentile of expected body weight)
10. Known lactose or gluten intolerance
11. Known allergy to cow’s milk proteins, fish, or any of the substances of the probiotic product or placebo
12. Patient who already participated and completed this study, and has repeated gastroenteritis while the enrolment into the study is still open
13. Patient participating in any other interventional clinical study
14. Patient with confirmed bacterial AGE and/or patient who need antibiotic treatment, will be excluded from the study
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute gastroenteritis (AGE) with evidence of dehydration
Digestive System
Acute gastroenteritis (AGE) with evidence of dehydration
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Intervention(s)
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Participants are randomised to one of two study arms in a 1:1 ratio using envelope randomisation.
Treatment arm: Participants receive Bio-Kult Infantis (an advanced probiotic multi-strain formula for infants with addition of prebiotics, omega 3 and vitamin D3) once a day for seven days, with an option to prolong teatment to ten days if no improvement is observed. The prolongation of the treatment will be the decision of the Investigator.
Control arm: Participants receive a placebo (product without probiotic organisms, prebiotics, omega-3 or vitamin D3 containing 100% maltodextrin) once a day for seven days, with an option to prolong teatment to ten days if no improvement is observed. The prolongation of the treatment will be the decision of the Investigator.
A week after the last dose of study treatment (i.e. day 15), the follow-up phone call will be performed to check the overall status of the patient and check for eventual adverse events.
The total duration of study per patient will be at least 15 days, and up to 18 days in case of the prolonged treatment.
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Primary Outcome(s)
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Duration of diarrhoea – “time to last diarrheal stool” is measured as the time in hours since the first time the Study Product is given until the last liquid/loose stool in the last 24 hours with at least three liquid/loose defecations.
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Secondary Outcome(s)
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Number of diarrheal episodes per day (frequency of defecation) is measured from patient diaries completed daily by the patient's caregiver throughout the study period.
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Source(s) of Monetary Support
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Probiotics International Ltd. (Protexin)
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Ethics review
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Status:
Approval date:
Contact:
National Medical Ethics Comittee of Republic of Slovenia
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2019 |
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URL:
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