Functional Constipation (FC)NCT07588633
Fiber Nutritional Supplement for Management of Constipation During Pregnancy
A study testing fiber supplement (PHGG) with counselling for constipation management in people with Functional Constipation (FC), run by Société des Produits Nestlé (SPN) at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- fiber supplement (PHGG) with counselling for constipation management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2026to 8 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Irma Silva Zolezzi, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Medcin Pesquisa Clínica
Osasco, São Paulo, 06023-070
Flávia Alvim S. Addor, Profa. Dra., +55 11 94311-7296, contato@medcindermatologia.com.br
About this study
Official title: 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.
- Conditions
- Functional Constipation (FC)
- Being tested
- fiber supplement (PHGG) with counselling for constipation management
- Keywords
- constipation, fiber, pregnancy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiber supplement (PHGG) with counselling for constipation managementDietary supplement
fiber supplement is in powder form and packaged in 6 gram sachets containing approximately 5.8 grams PHGG
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Fiber Nutritional Supplement with constipation counselling Receives: Dietary Supplement: fiber supplement (PHGG) with counselling for constipation management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start8 May 2026
- Primary completion8 Aug 2026
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label, single-arm intervention
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flávia SantAnna Addor, Principal investigator, MEDCIN PESQUISA CLINICA LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588633
- Sponsor's protocol ID
- 26.01NPTC
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No