Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04958460 |
| Other study ID # |
201901479A3C601 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
May 14, 2020 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut
microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators
previously found the relative abundance of Sutterella stercoricanis were increased and
Bifidobacterium bifidum were decreased in the ADHD group. Investigators hypothesize that ADHD
patients receiving supplementary Bifidobacterium bifidum (Bf-688) is able to increase the
proportion of Bf-688; inhibit the proportion of Sutterella; and improve ADHD symptoms.
Description:
Aims:
Investigators will conduct an open-label, single arm study and a randomized, double-blind
clinical trial to examine whether Bf-688 can achieve similar effects to therapeutic drugs for
ADHD.
Methods:
The duration of this clinical trial is expected to be 2 years (March 2020 to February 2022).
1. In the first stage of study, investigators will conduct an open-label, single arm study.
Investigators will recruit 30 children aged 4-16 who are diagnosed as ADHD who are
eligible to participate in the trial. The patients will be administrated with Bf-688, 1
pack each morning and evening (5×109 colony forming units (CFUs) per day) for 8 weeks.
At the baseline, 2nd, 4th and 8th week, the clinical symptoms of ADHD will be evaluated
using the SNAP-IV and ADHD-RS. At weeks 0 and 8, blood samples and fecal samples will be
collected and psychological tests will be performed.
2. In the second stage of study, This clinical trial is a prospective, randomized,
double-blind, parallel-controlled clinical trial for children aged 6-12 years old who
are diagnosis of ADHD and who are currently receiving ADHD drug therapy. A total of 120
patients will be recruited in this trial. All subjects will be randomly assigned
(allocation ratio 1:1) to one of the following two groups (60 people in each group):
(1) Probiotics group: The original ADHD drug will be continuously used, and the Bf-688 packet
(5×109 CFUs) will be administrated in the morning and in the evening daily.
(2) Placebo group: The original ADHD drug will be continuously used, and the placebo packet
will be administrated in the morning and in the evening daily.
The patients will take the above prescription for 12 consecutive weeks. At the 0th, 4th, 8th,
and 12th weeks, parents and teachers will be asked to fill SNAP-IV, and the researcher will
use ADHD-RS to evaluate the clinical symptoms of ADHD. At the 0th week and 12th week, stool
samples will be collected and psychological tests will be performed (CPT and CATA). Nucleic
acid sequencing technology is used to identify bacterial species in feces, and
high-throughput 16S rRNA sequences can be quickly obtained through Next Generation Sequencing
(NGS), and fecal metabolites analysis.
Expected results:
Investigators expect to find that Bf-688 exhibit significant better effects than the placebo
group for treating ADHD patients. This result will validate that gut microbiota modification
may be beneficial for the behavioral symptoms of ADHD children, and the outcome may have the
potential for patent and commercialization.
