Fiber Nutritional Supplement for Management of Constipation During Pregnancy

Effectiveness of Daily Supplementation of a Fiber Nutritional Supplement (Materna® Opti-fiber) and Counselling for Constipation Management in Pregnancy

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 Overview

• Status: Not yet recruiting
• Conditions: Functional Constipation (FC)
• Intervention / Treatment: Dietary supplement: fiber supplement (PHGG) with counselling for constipation management

• Study Type: Interventional
• Enrollment (Estimated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Iroz, PhD; Phone Number: +44763720486; Email: alison.petit-jean@nestle.com
• Study Contact Backup: Name: Irma Silva Zolezzi, PhD; Email: Irma.SilvaZolezzi@nestle.com

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Medcin Pesquisa Clínica
      • Contact: Flávia Alvim S. Addor, Profa. Dra.; Phone Number: +55 11 94311-7296; Email: contato@medcindermatologia.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Fiber Nutritional Supplement with constipation counselling	Dietary supplement: fiber 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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	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.	4 weeks

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Flávia SantAnna Addor, MEDCIN PESQUISA CLINICA LTDA

Study record dates

Study Major Dates

• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): October 8, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; constipation; fiber
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation
• Other Study ID Numbers: 26.01NPTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No