the Safety and Efficacy of N-acetyl Cysteine and Lactobacillus in Children With Drug-Resistant Epilepsy

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at investigating the possible efficacy and safety of Lactobacillus probiotic or N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Patients aged 3-18 years with intractable childhood-onset epilepsy.

• All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.

• The subject is willing and able to comply with the study requirements

Exclusion Criteria:

• Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR < 60 mL/min/1.73 m2 or electrolyte imbalance.

• Patients who are currently using or used antibiotics therapy in the preceding month

• Patients who are currently using or used other probiotic products in the preceding two weeks

• Patients scheduled to undergo GIT surgery or those underwent GIT surgery

• Patients with Known allergy to probiotics or N-acetyl cysteine.

• Patients receiving artificial enteral or intravenous nutrition

• Patients taking antioxidant and/or anti-inflammatory medications