An interventional study of fiber supplement (PHGG) with counselling for constipation management in Functional Constipation (FC), sponsored by Société des Produits Nestlé (SPN). Recruiting at 1 site in Brazil. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Treatment
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 31 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 4 weeks
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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2026 to primary completion in Aug 2026, 3 months.
Of 71 industry-sponsored interventional studies with no phase under Constipation, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 3 months is below that.
Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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