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Table 1 Trial design

From: Open-label pilot for treatment targeting gut dysbiosis in myalgic encephalomyelitis/chronic fatigue syndrome: neuropsychological symptoms and sex comparisons

Week 1 2 3 4 5 6
Day 1–7 8–14 15–21 22–28 29–35 36–42
Phase Screening/recruitment Baseline Intervention Post-intervention
Treatment prescribed    Antibiotic
Erythromycin
400 mg/b.d.
Probiotic
Pro4-50 d-Lactate Free Multistrain
1 tablet b.d.
Antibiotic
Erythromycin
400 mg/b.d.
Probiotic
Pro4-50 d-Lactate Free Multistrain
1 tablet b.d.
 
Measures/
monitoring
• Consent forms
• Screening and background questions
• Stool and urine collection
Day 1
• Cognitive test battery
Days 17
• Actigraphy
• Sleep diary
• MAC
• MFTQ
Day 7 a
• SSH
• DASS-21
• MFI-20
• POMS
• PSQI
• ISI
Day 14
• Phone call, symptom monitoring
Day 21
• Phone call, symptom monitoring
Day 28
• Phone call, symptom monitoring
Day 35
• Phone call, symptom monitoring
Day 1
• Cognitive test battery
Days 17
• Actigraphy
• Sleep diary
• MAC
• MFTQ
• Stool and urine collection
Day 7 a
• SSH
• DASS-21
• MFI-20
• POMS
• PSQI
• ISI
  1. aParticipants had the option of completing these scales at any time during Baseline and Post-intervention phases if they wanted to reduce the risk of post-exertional mental fatigue