Phase
Condition
Constipation
Treatment
PHGG
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men or women aged 18-75.
Adapted Rome IV Criteria of functional constipation* or IBSconstipation** for aminimum of 3 months
*1-2 SBM/week and at least 1 of the following at least 30% of the time:
Bristol stool scale 1-2
Straining
Sense of incomplete evacuation
Sense of stool blockage
Need of digital maneuvers
- Subjects with IBS-C: the above constipation criteria + abdominal pain areallowed.
Ability to understand the participant information sheet and instructions, and ableto provide informed consent.
Access to a suitable smartphone device (Android or iOS) with ability to download andcomplete the study e-Diary daily for the duration of the trial.
Exclusion
Exclusion Criteria:
Pregnant women or breastfeeding.
Organic chronic gastrointestinal disease or complication (such as, but not limitedto, Inflammatory Bowel Disease, Microscopic colitis, Eosinophilic gastroenteritis,Radiation-related enterocolitis, Coeliac disease).
Subjects with a diagnosed food allergy or hypersensitive to any of the components ofthe study product.
Subjects with chronic diarrhea.
Active peptic ulcer.
Major gastrointestinal or colonic surgery (such as, gastric bypass or any otherobesity or metabolic interventions including endoscopic procedures or devices, anygastro-intestinal or colonic resection); cholecystectomy and appendectomy areallowed.
Neurologic or other clinically significant comorbid diseases that may affectgastrointestinal function, such as multiple sclerosis, spinal cord injury orHirschsprung disease.
Illness that may preclude the participant's ability to complete the study or thatmay confound the study outcomes (e.g. bowel cancer, prostate cancer, terminalillness, severe cardiovascular disease, chronic renal failure or eating disorders)or any other serious illness resulting in >2 weeks inability to work in the 3 monthsbefore the study start.
Participants with clinically significant (as per physician judgement) co-morbidillnesses such as cardiovascular, endocrine (e.g. hypothyroidism, diabetes), renal,or other chronicdisease (e.g. reduced mobility or increased fragility).
Active alcohol, drug, or medication abuse (as per clinician judgement).
Self-reported symptoms suggestive of pelvic organ prolapse as per clinicianjudgement, such as feeling of pressure or fullness in the pelvic area, intra vaginaldiscomfort, painful intercourse, and urinary problems.
Moderate or severe active local anorectal problems such as recurrent anal fissures,frequent bleeding, large prolapsing hemorrhoids.
Any clinically relevant abnormalities detected during the physical examination orany alarm features in the medical history such as sudden unintentional weight loss (>10% in 3 months), frequent rectal bleeding not caused by anal fissures orhemorrhoids, recent change in bowel habit (<3 months), severe abdominal pain andstool positive for occult blood.
Regular (i.e. daily or weekly) use of PHGG within 6 months of screening.
Participation in another study with any investigational product within 6 months ofrandomization for drug study and within 2 months of randomization for a nutritionalstudy.
Investigator believes that the participant is physically or mentally unfit toparticipate in the trial.
Participants currently of childbearing potential, but not using an effective methodof contraception, as determined by the investigator.
Any participant who is an employee of the study site or an Atlantia Clinical Trialsemployee or their close family member or a member of their household.
Study Design
Connect with a study center
Atlantia Food Clinical Trials
Cork, T23 R50R
IrelandSite Not Available

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