This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being.
The study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.
Pregnant women aged 21 years-old or above at recruitment
Gestational age of 13-27 weeks at recruitment
Singleton pregnancy at recruitment
Low frequency of stool (<3/week)
Treated for constipation less than one week before the start of the study
Use of prebiotics or probiotics containing supplements two weeks prior to the study start
Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
Single group
fiber supplement (PHGG) with counselling for constipation management
Dietary supplementfiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG
Change in stool frequency from baseline to 4 weeks of intervention
Change in stool frequency from baseline (V1) to 4 weeks of intervention (V2) assessed using a Gut Health Questionnaire to capture transit time and frequency.
Stool consistency including presence of diarrhoea
Change in stool consistency from baseline (V1) to 4 weeks of intervention (V2) based on a 7-point Bristol Stool Scale (1=Hard, 7= Watery), including self-reported presence of diarrhoea.
Symptoms of constipation
percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week
Symptoms of gut discomfort
Frequencey of self-reported presence of abdominal pain, abdominal discomfort abdominal bloating, gassiness / flatulence), and/or pain during defecation (completed at V2 only following 4 weeks of intervention)
Healthcare and pharmacological utilization
Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health
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