Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus - Randomized, Double Blind, Placebo Controlled Trial, Phase 4
Brief Summary: Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections.

Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated.

Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM.

Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects.

Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are:

1. The rate of women requiring medications for glycemic control
2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.


Options:
A: Arm Label: Nutritional counseling & self blood glucose monitoring; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: nutritional counseling, Behavioral: self blood glucose monitoring | Arm Label: No treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: nutritional counseling; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring | Intervention Type: BEHAVIORAL; Name: self blood glucose monitoring; Assigned to Arm(s): Nutritional counseling & self blood glucose monitoring
B: Arm Label: Probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Probiotics and Fish oil; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Comparison of probiotics, fish oil and their combination to placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Comparison of probiotics, fish oil and their combination to placebo; Assigned to Arm(s): Fish oil, Placebo, Probiotic, Probiotics and Fish oil
C: Arm Label: Probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotics | Arm Label: Probiotics + Dietary counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and probiotics | Arm Label: Dietary counseling + placebo; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and placebo | Arm Label: Prebiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Prebiotics | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsules | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary counselling and placebo; Assigned to Arm(s): Dietary counseling + placebo | Intervention Type: BEHAVIORAL; Name: Dietary counselling and probiotics; Assigned to Arm(s): Probiotics + Dietary counseling | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsules; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotics; Assigned to Arm(s): Probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotics; Assigned to Arm(s): Prebiotics
D: Arm Label: probiotic femina II; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Femina II | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Femina II; Assigned to Arm(s): probiotic femina II | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D