Condition category
Digestive System
Date applied
13/07/2016
Date assigned
14/07/2016
Last edited
14/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute gastroenteritis (AGE) is a common condition which involves sudden inflammation (swelling) of the lining of the stomach due to a viral infection. It affects people of all ages, but is most common in young children. One of the main symptoms is diarrhoea, which if lasts for more than three days can be cause severe dehydration (loss of fluids). Probiotics are living microorganisms, which are thought to have a positive influence health. Among the most commonly used are lactic bacteria, as they are naturally present in the gut and help with digestion (so called “good bacteria”). Probiotics are mainly available as food additives, such as yogurts, or in supplements. Bio-Kult Infantis is an advanced, multi-strain formula for babies, toddlers and young children containing seven strains of live bacteria with addition of prebiotics, Omega-3 fatty acids and Vitamin D3. Previous studies have shown that it can be beneficial in the treatment of gastroenteritis symptoms and can help speed up diarrhoea recovery. This may be due to the probiotic replenishing the “good bacteria” lost as a result of the diarrhoea. The aim of the study is to investigate the effectiveness of Bio-Kult Infantis in the treatment of diarrhoea.

Who can participate?
Children aged between six months and six years that seek medical attention for AGE and receive rehydration therapy but do not have to stay in hospital.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group eat the Bio-Kult Infantis product once a day for seven days. Participants in the second group eat a placebo (dummy) formula for seven days. For both groups, if there is no improvement within seven days, the researcher can extend the length of treatment to ten days. Parents of children in both groups are given a diary in which they are asked to record the number of diarrhoea episodes. Once week after the end of treatment, parents of children in both groups are telephoned in order to check when the diarrhoea stopped and to find out if there were any side effects from the formula.

What are the possible benefits and risks of participating?
Participants who receive the Bio-Kult Infantis may benefit from a faster recovery from their diarrhoea. Bio-Kult Infantis, has been on the market for some time and there have been no confirmed negative reactions reported in connection its use. Therefore, there are no predicted risks for children taking part.

Where is the study run from?
1. General Hospital Jesenice (Slovenia)
2. General Hospital Novo mesto (Slovenia)
3. University Hospital Centre Osijek (Croatia)
4. University Hospital Centre Rijeka (Croatia)
5. Hospital for Infectious Diseases (Croatia)

When is the study starting and how long is it expected to run for?
September 2015 to December 2016

Who is funding the study?
Probiotics International Ltd. (Protexin) (UK)

Who is the main contact?
Mrs Mojca Fir

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Mojca Fir

ORCID ID

Contact details

Vizera d.o.o.
Vojkova 4
Ljubljana
1000
Slovenia

Additional identifiers

EudraCT number

NA

ClinicalTrials.gov number

NA

Protocol/serial number

BKI-01

Study information

Scientific title

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

Acronym

Infantis

Study hypothesis

The aim of the study is to show the effectiveness of Bio-Kult Infantis as an adjuvant therapy in treating acute diarrhoea, compared to placebo.

Ethics approval

National Medical Ethics Comittee of Republic of Slovenia

Study design

Paediatric multi-centre randomized double-blind 2 arm parallel placebo-controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Acute gastroenteritis (AGE) with evidence of dehydration

Intervention

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.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/09/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

186

Participant 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

Recruitment start date

15/07/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

Croatia, Slovenia

Trial participating centre

General Hospital Jesenice
Department of Paediatrics Cesta maršala Tita 112
Jesenice
4270
Slovenia

Trial participating centre

General Hospital Novo mesto
Department of Paediatrics Šmihelska cesta 1
Novo mesto
8000
Slovenia

Trial participating centre

University Medical Centre Ljubljana
Department of Paediatrics Zaloška cesta 7
Ljubljana
1000
Slovenia

Trial participating centre

University Hospital Centre Osijek
Department of Paediatrics Joseph Huttlera 4
Osijek
31000
Croatia

Trial participating centre

University Hospital Centre Rijeka
Department of Paediatrics Krešimirova 42
Rijeka
51000
Croatia

Trial participating centre

Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Department of Paediatrics Mirogojska 8
Zagreb
10000
Croatia

Sponsor information

Organisation

Probiotics International Ltd. (Protexin)

Sponsor details

Lopen Head
Somerset
Somerset
TA13 5JH
United Kingdom

Sponsor type

Industry

Website

http://www.protexin.com

Funders

Funder type

Industry

Funder name

Probiotics International Ltd. (Protexin)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes