Condition category
Mental and Behavioural Disorders
Date applied
11/04/2019
Date assigned
02/05/2019
Last edited
26/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The bacteria in the gut are known to influence the brain and behaviour in animal models. Gut symptoms are common in ADHD and autism. The study aim is to explore if a food supplement with anti-inflammatory lactic acid bacteria and fibers attenuates psychiatric symptoms and functioning in persons with ADHD.

Who can participate?
Those with an ADHD diagnosis and no autism diagnosis aged 5-55 years and understanding Swedish.

What does the study involve?
Nine weeks with daily intake of 10 g of food supplement or placebo, a 30 minutes interview with a research nurse on psychiatric health and answering questionnaires on psychiatric health, as well as sampling of blood, urine and feces at start and after the 9 weeks.

What are the possible benefits and risks of participating?
Benefits: the treatment may improve the symptoms and functioning. It is possible for anyone to continue the treatment after the trial since the food supplement is commercially publicly available. Risks: no side effects have been reported for this food supplement.

Where is the study run from?
Karolinska Institutet in Stockholm.

When is the study starting and how long is it expected to run for?
The study started in 2016 and the last sampling was done in August 2018.

Who is funding the study?
The Swedish Research Council, the Swedish Brain Foundation, Ekhaga Foundation and PRIMA child and adult psychiatry Stockholm AB.

Who is the main contact?
Associate Professor Catharina Lavebratt
Catharina.Lavebratt@ki.se

Trial website

via https://ki.se/en/people/catlav

Contact information

Type

Scientific

Primary contact

Prof Catharina Lavebratt

ORCID ID

http://orcid.org/0000-0003-4987-2718

Contact details

Karolinska hospital L8:00
Stockholm
17176
Sweden
+46851776524
catharina.lavebratt@ki.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

BAMBA_1

Study information

Scientific title

Randomized placebo-controlled trial in children and adults with ADHD of the effect of Synbiotic2000Forte on symptoms and function.

Acronym

BAMBA

Study hypothesis

Synbiotic2000Forte improves symptoms and/or function in ADHD

Ethics approval

Approved 24/07/2015 and 23/02/2017, The Regional Review Board, Stockholm (The Swedish Review Board, Box 2110, 750 02 Uppsala; +4610-4750800; registrator@etikprovning.se), ref: 2015/884-31/1 and 2017/91-31.

Study design

Interventional study, multicenter double-blinded parallel randomized placebo-controlled trial.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Attention-deficit hyperactivity disorder

Intervention

Synbiotic2000 or placebo, 1 bag daily, 9 weeks treatment, follow-up for both treatments. Randomisation by external in blocks of 10 by external unit.

Active treatment: Synbiotic being is a composition of 4x10exp(11) CFU per dose of three lactic acid bacteria Pediococcus pentosaceus 5-33:3/16:1 (Strain deposit number: LMG P20608), Lactobacillus casei ssp paracasei F19 (LMG P-17806), Lactobacillus plantarum 2362 (LMG P-20606), and 2.5 g of each of the fermentable fibers betaglucan, inulin, pectin and resistant starch.

Placebo 10 g
One dose per day oral intake on foods for 9 weeks

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

1. Symptoms of inattention, hyperactivity/impulsivity is measured using ASRS for adults and SNAP-IV for children at baseline and 12 weeks.
2. Symptoms of autism is measured using AQ for adults and SCQ for children at baseline and 12 weeks.
3. Function is measured using WFIRS at baseline and 12 weeks.

Secondary outcome measures

1. Emotional regulation is measured in adults using DERS-16 at baseline and 12 weeks.
2. Insomnia is measured using KSQ for adults and ISI for children at baseline and 12 weeks.
3. Well-being is measured in adults using the well-being scale at baseline and 12 weeks.
4. Gastrointestional symptoms is measured using the Bristol Stool Scale and one pain question at baseline and 12 weeks.
5. Plasma immune activity markers is measured using multiplex immunoassays at baseline and 12 weeks.
6. Plasma bacterial metabolites e.g. short chain fatty acids is measured using LC-MS/MS at baseline and 12 weeks.
7. Feces microbiome is measured using shot gun sequencing at baseline and 12 weeks.

Overall trial start date

20/08/2015

Overall trial end date

24/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. ADHD diagnosis
2. Swedish speaker
3. Aged 5-55 years old

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

248

Total final enrolment

248

Participant exclusion criteria

1. Autism diagnosis
2. Gastrointestinal diagnosis other than IBS
3. Diabetes
4. Antibiotic drug treatment last six weeks

Recruitment start date

10/01/2016

Recruitment end date

20/08/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

PRIMA child adolescent and adult psychiatry
Götgatan 71
Stockholm
11621
Sweden

Sponsor information

Organisation

Karolinska Institutet

Sponsor details

L1:03
Stockholm
171 76
Sweden
+46851770000
info@ki.se

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Vetenskapsrådet

Alternative name(s)

Swedish Research Council, VR, SRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Sweden

Funder name

Hjärnfonden

Alternative name(s)

Swedish Brain Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Ekhaga Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

PRIMA psychiatry AB

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in high-impact peer-reviewed journal.

IPD sharing statement: The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication after anonymisation.

Intention to publish date

20/05/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/04/2019: Trial's existence confirmed by The Regional Review Board, Stockholm.