Functional Constipation (FC)
Conditions
Keywords
constipation, fiber, pregnancy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTfiber supplement (PHGG) with counselling for constipation management
fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, single-arm intervention
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women aged 21 years-old or above at recruitment 2. Gestational age of 13-27 weeks at recruitment 3. Singleton pregnancy at recruitment 4. Suffering from functional constipation according to the Cullen 2007 criteria which must include ALL the following and the criteria must be fulfilled for at least two weeks with symptom onset during pregnancy: 1. Low frequency of stool (\<3/week) 2. Hard stools 3. Difficulty on evacuation 5. Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment. 6. Willing and able to comply with the requirements for participation in this study 7. Willing and able to refrain from consuming other supplements containing fiber, prebiotics, or probiotics other than the Fiber Nutritional Supplement (Materna® Opti-fiber) over the intervention period 8. Able to respond to questionnaires in English
Exclusion criteria
1. Treated for constipation less than one week before the start of the study 2. Use of prebiotics or probiotics containing supplements two weeks prior to the study start 3. 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 4. 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 5. Not willing and/or not able to comply with the study procedures and requirements 6. Known serious food allergy 7. Known or suspected history of allergy or intolerance to the investigational product (IP) 8. Active participation in another clinical trial or on-going observational study 9. Family or hierarchical relationships with the research team members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool frequency from baseline to 4 weeks of intervention | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency including presence of diarrhoea | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | 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 | 4 weeks | Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health |
| Product acceptance | 4 weeks | 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. |
Countries
Brazil
Contacts
CONTACTAlison Iroz, PhD
CONTACTIrma Silva Zolezzi, PhD
PRINCIPAL_INVESTIGATORFlávia SantAnna Addor
MEDCIN PESQUISA CLINICA LTDA
Outcome results
None listed