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Not yet recruiting NCT07588633

Fiber Nutritional Supplement for Management of Constipation During Pregnancy

No phase Interventional Functional Constipation (FC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fiber supplement (PHGG) with counselling for constipation management.
Who it may be relevant to
Registry conditions: Functional Constipation (FC). Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 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

Primary outcome measures

  • Change in stool frequency from baseline to 4 weeks of intervention [Time frame: 4 weeks]
Secondary outcome measures (5)
  • Stool consistency including presence of diarrhoea [Time frame: 4 weeks]
  • Symptoms of constipation [Time frame: 4 weeks]
  • Symptoms of gut discomfort [Time frame: 4 weeks]
  • Healthcare and pharmacological utilization [Time frame: 4 weeks]
  • Product acceptance [Time frame: 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Medcin Pesquisa Clínica — Osasco

Identifiers

NCT: NCT07588633 · 26.01NPTC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗