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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG
Medcin Pesquisa Clínica
Osasco, São Paulo, Brazil
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Symptoms of constipation
percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week
Time frame: 4 weeks
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)
Time frame: 4 weeks
Healthcare and pharmacological utilization
Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health
Time frame: 4 weeks
Product acceptance
Self-reported score rom 1 - 5, where 1 = "Very poor", 5 = "Excellent" on product acceptance and ease of use after 4 weeks of intervention (completed at V2 only) using a questionnaire developed for the study.
Time frame: 4 weeks
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