Fiber supplement aims to ease pregnancy constipation
NCT ID NCT07588633
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily fiber supplement (Materna® Opti-fiber) plus nutrition counseling can help pregnant women with constipation. About 31 women between 13 and 27 weeks of pregnancy will take the supplement for 4 weeks. Researchers will track changes in stool frequency and consistency.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fiber supplement (partially hydrolyzed guar gum with vitamins C, D, zinc, selenium)
- What this could lead to
- If it works, this could offer a simple, safe way to manage constipation during pregnancy and improve quality of life.
- What could go wrong
- This is a very small, early study with no control group, so results may not be reliable. The supplement may not work better than diet changes alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medcin Pesquisa Clínica
Osasco, São Paulo, 06023-070, Brazil
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