Treatment of ADHD with synbiotics (probiotics plus prebiotics)
| ISRCTN | ISRCTN57795429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57795429 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | BAMBA_1 |
| Sponsor | Karolinska Institutet |
| Funders | Vetenskapsrådet, Hjärnfonden, Ekhaga Foundation, PRIMA psychiatry AB |
- Submission date
- 11/04/2019
- Registration date
- 02/05/2019
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Karolinska hospital L8:00
Stockholm
17176
Sweden
 ORCID ID |
0000-0003-4987-2718 |
|---|---|
| Phone | +46851776524 |
| catharina.lavebratt@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional study, multicenter double-blinded parallel randomized placebo-controlled trial. |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Randomized placebo-controlled trial in children and adults with ADHD of the effect of Synbiotic2000Forte on symptoms and function. |
| Study acronym | BAMBA |
| Study objectives | Synbiotic2000Forte improves symptoms and/or function in ADHD |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Symptoms of inattention, hyperactivity/impulsivity is measured using ASRS for adults and SNAP-IV for children at baseline and 12 weeks. |
| Key secondary outcome measure(s) |
1. Emotional regulation is measured in adults using DERS-16 at baseline and 12 weeks. |
| Completion date | 24/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 248 |
| Total final enrolment | 182 |
| Key inclusion criteria | 1. ADHD diagnosis 2. Swedish speaker 3. Aged 5-55 years old |
| Key exclusion criteria | 1. Autism diagnosis 2. Gastrointestinal diagnosis other than IBS 3. Diabetes 4. Antibiotic drug treatment last six weeks |
| Date of first enrolment | 10/01/2016 |
| Date of final enrolment | 20/08/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
11621
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication after anonymisation. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Symptoms and daily functioning | 01/10/2020 | 26/10/2020 | Yes | No |
| Results article | Plasma immune activity markers and short-chain fatty acids | 06/03/2023 | 14/06/2023 | Yes | No |
| Results article | Bacterial gut microbiome | 20/03/2023 | 03/03/2025 | Yes | No |
| Results article | Plasma concentrations of short-chain fatty acids | 03/03/2025 | Yes | No | |
| Results article | Proinflammatory mediators | 01/06/2020 | 03/03/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/03/2025: Publication references added.
14/06/2023: Publication reference added.
26/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
26/04/2019: Trial's existence confirmed by The Regional Review Board, Stockholm.
