Clinical trial

Effect of Bifidobacterium Bifidum (Bf-688) on Clinical Characteristics and Gut Microbiota in Attention-deficit/Hyperactivity Disorder: a Double-blind Randomized-control Trial

Name

201901479A3C601

Description

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.

Trial arms

Trial start

2020-05-14

Estimated PCD

2023-02-28

Trial end

2023-02-28

Status

Completed

Phase

Early phase I

Treatment

Placebo

Administrated 1 packet of maltodextrin (as placebo of Bf-688) in the morning and evening

Arms:

Control group

BF688

Administrated 1 pack each morning and evening (5×109 CFUs per day)

Arms:

Probiotics group

Size

150

Primary endpoint

Kiddie-Schedule for Affective Disorder and Schizophrenia-Epidemiological Ver- sion (K-SADS-E)

At the baseline

The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

At the baseline

The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

2nd week

The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

4th week

The Chinese version of Swanson, Nolan and Pelham IV Scale (SNAP-IV)

8th week

Eligibility criteria

Inclusion Criteria: * ADHD Exclusion Criteria: * Autism * MR * Developmental Delay * Vegetarian

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}

Updated at

2023-04-06

1 organization

1 drug

5 indications

Organization

Drug

Indication

Indication

Indication

Indication

Indication