An Early Phase 1 interventional study of Probiotic Formula lacteal forte in Inattentive, Hyperactivity and Impulsivity, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-27.
Sponsored by Ain Shams University · Early Phase 1, Interventional, and Treatment
ADHD is a neurodevelopmental disorder characterized by persistent symptoms of inattention and/or hyperactivity and impulsivity that are present before age 18. These symptoms must be evident across ADHD treatment is currently based on a multimodal approach with the combination of psychotherapy and pharmacotherapy, but no reliable markers of treatment response have been identified yet and 20-35% of subjects in clinical trials may have an inadequate response to the treatment The gut microbiome refers to the microbial ecosystem found in the gastrointestinal system of the human species Probiotics are a type of beneficial bacteria that improve health and facilitate intestinal microbial balance Increasing evidence suggests that the gut microbiota plays a key role in the gut-brain communication axis by influencing metabolism, inflammation, the hypothalamic-pituitary-adrenal axis, and neurotransmission multiple domains and cause Impairment in functioning in order to meet the diagnostic criteria for ADHD
All patients will be randomly distributed into two equal groups using a random number generator from computer-based randomization software. the probiotic group (n=40) received probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony-forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks added to a weight-dependent dose of standard treatment (Atomoxetine), and the 40 patients in the control group will not receive the probiotic and on a weight-dependent dose of atomoxetine.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
patients (n=40) will receive probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks added to standard treatment
Drug: Probiotic Formula lacteal forte
ADHD patient (40) on standard treatment
Active Comparator: Patient with attention deficit hyperactive disorder patients (n=40) will receive probiotic preparation twice daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks .
Also known as: Lacteal forte
Conner's Parent Rating Scales-Revised (CRS-R):for follow up
This tool is used in order to assess the profile and severity of symptoms, response to treatment and follow up studies. Items are scored on 14 subscales of symptoms including opposition, cognitive problems, inattention, and hyperactivity.It is usually considered normal when T-scores are less than 60, while scores above 60 are signs of academic, behavioral, or social issues. There are several different classes as well
Time frame: 3 months
Child behavior checklist
Parent form to asses the associated internalizing and externalizing behaviour
Time frame: 3 months
Conners Continuous Performance Test (CPT)
To asses sustained attention and impulsivity
Time frame: 3 months
Wisconsin (Berg) Card Sort Test (WCST)
To evaluate executive function
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Ain Shams University