A study Comparing Probiotic Treatment Along With Standard Care versus Standard Care Alone in People with Delirium Due to Alcohol Use

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Probiotic Capsule: Each oral capsule contains clinically validated strains of Lactobacillus species, delivering one billion colony forming units at the time of manufacture. The probiotic is sourced from a GMP certified manufacturer. One capsule is administered orally twice daily, in the morning and evening, for fourteen consecutive days, beginning within twenty four hours of randomization. The capsules are stored below twenty five degree Celsius, protected from light and moisture, as per manufacturer instructions. Capsules are administered by trained nursing staff as part of routine medication rounds, with one hundred and fifty millilitre of non heated water to ensure maximum probiotic viability. Adherence and tolerability are documented throughout the study. The intervention duration is 14 consecutive days. Control Intervention1: Placebo Capsule: Each capsule contains inert excipients such as microcrystalline cellulose and maltodextrin. Placebo capsules match the active capsules in appearance, weight, size, shape, odor, and packaging to maintain blinding. One capsule is administered orally twice daily, for fourteen consecutive days, identical to the intervention arm. Storage conditions and administration procedures are identical to those of the intervention. Adherence and tolerability are systematically monitored and recorded. CONDITION: Health Condition 1: F102‐ Alcohol dependence PRIMARY OUTCOME: Time to sustained recovery from Delirium Tremens, defined as first occurrence of a Delirium Rating Scale Revised ninety eight score below ten sustained for forty eight hoursTimepoint: Baseline till day fourteen (measured daily) SECONDARY OUTCOME: Change in Clinical Institute Withdrawal Assessment for Alcohol total score from baseline ; Timepoint: Baseline, day three, day seven, day fourteen Change in Gastrointestinal Symptom Rating Scale and Stool Form scores from baseline ; Timepoint: Baseline, day seven, day fourteen Change in gut microbiota composition and functional potential, measured by whole metagenome sequencing of stool samples ; Timepoint: Baseline, day fourteen Change in Montreal Cognitive Assessment total score from baselineTimepoint: Baseline, day three, day seven, day fourteen Change in serum levels of inflammatory markers including C reactive protein, Interleukin one beta, Interleukin six, Tumor Necrosis Factor alpha, and standard liver function test parameters ; Timepoint: Baseline, day three, day seven, day fourteen INCLUSION CRITERIA: Males and females aged 18‐70 years Diagnosis of Delirium Tremens based on DSM 5 criteria. History of chronic alcohol use for more than 2 years. Admitted for treatment of Alcohol Withdrawal Syndrome. Provision of signed informed consent by the participant, if deemed to have the capacity to provide consent at enrollment or by their Legally Authorized Representative.
Epistemonikos ID: e9e825abddaa835058053b24f753c7c7878cc4bc
First added on: Oct 08, 2026