Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07588633

Fiber Nutritional Supplement for Management of Constipation During 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Functional Constipation (FC) Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged 21 years-old or above at recruitment
  • Gestational age of 13-27 weeks at recruitment
  • Singleton pregnancy at recruitment
  • 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:
  • Low frequency of stool (<3/week)
  • Hard stools
  • Difficulty on evacuation
  • Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.
  • Willing and able to comply with the requirements for participation in this study
  • 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
  • Able to respond to questionnaires in English

Exclusion criteria

  • 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
  • Not willing and/or not able to comply with the study procedures and requirements
  • Known serious food allergy
  • Known or suspected history of allergy or intolerance to the investigational product (IP)
  • Active participation in another clinical trial or on-going observational study
  • Family or hierarchical relationships with the research team members

Treatment and study plan

fiber supplement (PHGG) with counselling for constipation management

Dietary Supplement

fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG

Primary outcomes

  1. Change in stool frequency from baseline to 4 weeks of intervention

    Time frame: 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 outcomes

  1. Stool consistency including presence of diarrhoea

    Time frame: 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.

  2. Symptoms of constipation

    Time frame: 4 weeks

    percent of participents with self-reported presence of hard/lumpy stool, straining, and/or less than 3 bowel movements per week

  3. Symptoms of gut discomfort

    Time frame: 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)

  4. Healthcare and pharmacological utilization

    Time frame: 4 weeks

    Healthcare and pharmacological utilization for issues related to GI health and absenteeism from work for issues related to GI health

  5. Product acceptance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Iroz, PhD

CONTACT

[email protected]

+44763720486

Irma Silva Zolezzi, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.