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

Table 1 Trial design

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 1–7 • 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 1–7 • Actigraphy • Sleep diary • MAC • MFTQ • Stool and urine collection Day 7 ^a • SSH • DASS-21 • MFI-20 • POMS • PSQI • ISI

^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

ISSN: 1479-5876