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Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.

Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06231849
Enrollment
52
Registered
2024-01-30
Start date
2024-02-29
Completion date
2026-04-30
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Opioid Use Disorder, Opioid Dependence

Keywords

gut microbiota ., Opioid use

Brief summary

This study will aim to investigate the gut microbiota in Egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.

Detailed description

Addiction is defined as a chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences. Pathological substance use disorders represent a major public health crisis with limited effective treatment options. Although the gut and brain are separate organs, they communicate with each other via trillions of intestinal bacteria that collectively make up one's gut microbiome. Findings from both humans and animals support a critical role of gut microbes in regulating brain function, mood, and behavior. Gut bacteria influence neural circuits that are notably affected in addiction-related behaviors. These include circuits involved in stress, reward, and motivation, with substance use influencing gut microbial abnormalities, suggesting significant gut-brain interactions in drug addiction. The investigator will discuss this role of gut microbiome in Assuit university hospital to see how the pathogenesis can be altered of drug addiction.

Interventions

DIAGNOSTIC_TESTstool analysis

stool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

1. Clinical and laboratory diagnosis of substance missuse. 2. Must be encountering withdrawal symptoms for the first time.

Exclusion criteria

1. An intelligence quotient (IQ) below 70. 2. Gastrointestinal diseases.

Design outcomes

Primary

MeasureTime frameDescription
Determine the psychiatric symptoms related to opioid misuse.3 months.The investigator will focus on the following scale: • The Symptom ChickList-90-Revised : psychiatric Symptom related to opioid misuse measured by symptom checklist.
Determine severity of misuse.3 months.Addiction severity index: is an assessment tool used to assess an adult's condition in 7 key problem areas that are typically affected by substance abuse, including medical status, employment, and more, it addresses 7 main aspects of a person's behavior and environment.1 The areas assessed include:1 Medical status. Employment and support. Drug use. Alcohol use. Legal status. Family/social status. Psychiatric status. substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows: 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Determine type of misuse(whether its just opioid or combined with other substances)3 months• Laboratory: Urine analysis for substance use(drug screen).

Secondary

MeasureTime frameDescription
Measuring abundance of gut microbiota6 monthsThe investigator will perform a stool analysis to determine changes in amount of gut microbiota in both intoxication phase and in recovery phase then after 3 month a follow-up test will be conducted to determine the percent of Relapse rate.

Contacts

Primary Contactahmed mohammed
ahmedbayoud956@gmail.com01069936008

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026