The impact of ingestion of Bifidobacterium longum NCC3001 on perinatal anxiety and depressive symptoms: a randomized controlled trial

Abstract

Perinatal mood disorders, including depression and anxiety, are common. Pregnant and lactating women often limit their use of medications, thus a safe and natural solution to improve mood would be welcomed. There is increasing evidence that probiotics such as Bifidobacterium longum NCC3001 can influence mental well-being of adults; however, their impact on mental health during pregnancy and after birth remains unknown. The current double-blind, placebo-controlled, randomized, 3-parallel-arm study (N = 184) evaluated the efficacy of orally consumed B. longum (BL) NCC3001 either during pregnancy and postpartum (from approximately 30 weeks' gestation until 12 weeks after delivery) or postpartum only (from birth until 12 weeks after delivery) compared to a placebo control group in reducing depressive and anxiety symptoms assessed by EPDS and STAI self-administered questionnaires in late pregnancy and across 12 weeks postpartum. Contrary to our hypothesis, we did not observe any differences between groups in mood outcomes. Mood scores showed large variability among participants, as well as notable fluctuations within individuals over the course of the study. Additionally, it should be noted that BL NCC3001 was not detected after the intervention in all of the intervention group participants. More research is needed to understand the underpinnings of perinatal mood disturbances and microbial changes, and whether probiotics could improve mood during this period.

Keywords: Gut-brain axis; Mood; Postpartum depression; Probiotics; Stress.

Fig. 1

Consolidated Standards of Reporting Trials (CONSORT) flowchart showing participant flow through the trial. Pre-P, Prenatal intervention; Post-P, Postpartum intervention; ITT = Intention-to-treat: all subjects randomized to one of the three arms; SAF = Safety analysis set: at least one investigational product intake; FAS = Full Analysis Dataset: at least one investigational product intake and post-randomized data; PP = Per Protocol: included in FAS and without any protocol deviation impacting primary analysis.

Fig. 2

Study design illustrating samples and data collected at each session. Validated questionnaires were used to assess depressive and anxiety symptoms at session 1 to session 6 (S1-6), sleep at S2 and S6, and parenting stress at S6. Saliva was collected to assess cortisol wakening response at S1-S6. Furthermore, stress was assessed through transdermal optical imaging at S1-S6. Maternal fecal samples were taken at S1, S2, S4 and S6.