An interventional study of Homemade whole milk kefir and Homemade skim milk kefir in Chronic Functional Constipation, sponsored by Cecilia Sepulveda. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Cecilia Sepulveda · Not applicable, Interventional, and Supportive care
Functional chronic constipation is a common digestive disorder in Chilean adults. It causes infrequent or difficult bowel movements, abdominal discomfort and a feeling of incomplete evacuation, and it can impair quality of life. Kefir is a fermented milk made with grains that contain lactic acid bacteria and yeasts. It has been proposed as a dietary option to relieve constipation, but its effects may depend on how it is prepared.
The purpose of this study is to evaluate whether daily intake of two homemade kefir formulations, one made with whole milk and one made with skim milk, improves constipation symptoms and quality of life in adults with functional chronic constipation, compared with dietary counseling alone.
Thirty adults of both sexes diagnosed with functional chronic constipation according to the Rome IV criteria will be randomly assigned to one of three groups (10 per group):
Whole-milk kefir (KLE) Skim-milk kefir (KLD) Control group receiving nutritional counseling based on the Chilean Dietary Guidelines only
Participants in the kefir groups will follow a gradual dose increase (50, 100, 150 and up to 200 mL/day) for 4 weeks. Both kefir formulations will be prepared under standardized conditions (6% grain inoculation, 48-hour fermentation) and characterized for their nutritional, microbiological and sensory properties before the trial.
The primary outcome will be constipation-specific quality of life, measured with the PAC-QOL questionnaire. Secondary outcomes will include constipation symptoms (Rome IV criteria), stool consistency (Bristol Stool Form Scale) and generic health-related quality of life (EQ-5D). Dietary intake (24-hour recall and food frequency questionnaire) and physical activity (GPAQ) will be recorded as potential confounders. All assessments will be done before and after the intervention.
The researchers expect that participants who drink kefir will improve their constipation symptoms and quality of life more than those who receive counseling only. They also expect a greater improvement with the whole-milk kefir
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 57 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with Cecilia Sepulveda as lead sponsor.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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The human immunodeficiency virus, which weakens the immune system.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
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Participants receive homemade kefir prepared with whole milk (6% grain inoculation, 48-hour fermentation), with an escalating daily dose of 50, 100, 150 and 200 mL. In addition to dietary counseling
Dietary Supplement: Homemade whole milk kefir · Behavioral: dietary counselling
Participants receive homemade kefir prepared with skim milk (6% grain inoculation, 48-hour fermentation), with an escalating daily dose of 50, 100, 150 and 200 mL. In addition to dietary counseling
Dietary Supplement: Homemade skim milk kefir · Behavioral: dietary counselling
Participants receive standardized dietary counseling for chronic functional constipation, without kefir supplementation.
Behavioral: dietary counselling
Homemade kefir produced by fermenting whole milk with kefir grains (6% inoculation, 48-hour fermentation). Administered orally once daily for 1 month. The dose is escalated every 24 hours during the first 3 days (50 mL on day 1, 100 mL on day 2, 150 mL on day 3), reaching 200 mL/day from day 4, which is maintained until the end of the intervention. Differs from the skim milk formulation in fat content. In addition a dietary couselling
Participants receive homemade skim milk kefir orally once daily for 1 month, with a dose escalated every 24 hours during the first 3 days (50, 100 and 150 mL) and maintained at 200 mL/day from day 4 until the end of the intervention.In addition a dietary couselling
Single standardized nutritional counseling session for chronic functional constipation, delivered by a registered dietitian at baseline after randomization, including recommendations on dietary fiber, fluid intake and eating habits. Participants are followed for 1 month.
Change from Baseline in the Number of Rome IV Diagnostic Criteria for Functional Constipation Met at 1 Month
Functional constipation symptoms were assessed with the Rome IV diagnostic criteria. Each participant was scored on six criteria: straining, lumpy or hard stools (Bristol Stool Form Scale types 1-2), sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, and manual maneuvers to facilitate defecation, each present in more than 25% of defecations, plus fewer than 3 spontaneous bowel movements per week. The score ranges from 0 (minimum, no criteria met) to 6 (maximum, all criteria met). Higher scores indicate more severe constipation, which is a worse outcome. At baseline, criteria were assessed according to the Rome IV time requirement (symptoms present during the last 3 months, with onset at least 6 months before diagnosis). At the end of the intervention, they were assessed for the 1-month intervention period. The change from baseline (number of criteria at the end of the intervention minus baseline) was compared between the homemade whole-milk kefir group
Time frame: Baseline and 1 month (end of intervention)
Change from Baseline in the Patient Assessment of Constipation Quality of Life (PAC-QOL) Overall Score at 1 Month
Constipation-specific quality of life was assessed with the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL). It is a self-administered instrument of 28 items grouped into four subscales: physical discomfort (4 items), psychosocial discomfort (8 items), worries and concerns (11 items) and satisfaction (5 items). Each item is rated on a 5-point Likert scale from 0 to 4. The satisfaction items are reverse-scored. The overall score is the mean of all items, and each subscale score is the mean of its items. Overall and subscale scores range from 0 (minimum) to 4 (maximum). Higher scores indicate worse quality of life. The change from baseline (overall score at the end of the intervention minus baseline) was compared between the homemade whole-milk kefir group, the homemade skim-milk kefir group and the standard dietary counseling group. A negative change indicates improvement in quality of life.
Time frame: Baseline and 1 month (end of intervention)
Change from Baseline in the Number of Bowel Movements per Week, as Recorded in a Self-Report Diary, at 1 Month
Participants recorded each bowel movement in a self-report diary. Weekly bowel movement frequency was calculated as the number of bowel movements per week. The change from baseline (weekly frequency at the end of the intervention minus baseline) was compared in two ways: first, between each homemade kefir group (whole milk and skim milk) and the standard dietary counseling group; second, between the homemade whole-milk kefir group and the homemade skim-milk kefir group. A positive change indicates an increase in bowel movement frequency, which is a better outcome.
Time frame: Baseline and 1 month (end of intervention)
Change from Baseline in Stool Consistency as Assessed by the Bristol Stool Form Scale at 1 Month
Participants recorded each bowel movement in a self-report diary. For the end-of-intervention value, the mean number of bowel movements per week was calculated from all diary records over the entire 1-month intervention period. The change from baseline (mean weekly frequency over the intervention period minus baseline frequency) was compared in two ways: first, between each homemade kefir group (whole milk and skim milk) and the standard dietary counseling group; second, between the homemade whole-milk kefir group and the homemade skim-milk kefir group. A positive change indicates an increase in bowel movement frequency, which is a better outcome. Unit of Measure: bowel movements per week
Time frame: Baseline and 1 month (end of intervention)
Change from Baseline in Health-Related Quality of Life as Assessed by the EQ-5D Index Score and EQ-5D Visual Analogue Scale (EQ VAS) at 1 Month
Health-related quality of life was assessed with the EuroQol 5-Dimension, 3-Level questionnaire (EQ-5D-3L), which has two components. The descriptive system covers five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each rated at three levels (no problems, some problems, extreme problems). Responses were converted into a single index score using the Chilean time trade-off value set (Zarate et al., 2011). The index ranges from \[value of minimum; values below 0 represent health states considered worse to 1 maximum; full health. The visual analogue scale (EQ VAS) records self-rated health on the day of assessment, from 0 (minimum; worst imaginable health) to 100 (maximum; best imaginable health). For both components, higher scores indicate better health status. The change from baseline (score at the end of the intervention minus baseline) was compared for each component in two ways: first, between each homemade kefir
Time frame: Baseline and 1 month ( end of intervention)
Sensory Acceptability of Homemade Whole-Milk and Skim-Milk Kefir as Assessed by a 7-Point Hedonic Scale at 1 Month
Sensory acceptability of the homemade kefir was assessed at the end of the intervention with a 7-point hedonic scale (Likert type) in participants allocated to the whole-milk or skim-milk kefir groups. Participants rated each sensory attribute (appearance, color, aroma, flavor, texture and overall acceptability) from 1 (minimum; dislike very much) to 7 (maximum; like very much), with 4 representing neither like nor dislike. Each attribute was scored separately. Higher scores indicate greater acceptability, which is a better outcome. The scores for each attribute were compared between the homemade whole-milk kefir group and the homemade skim-milk kefir group. Participants in the standard dietary counseling group did not consume kefir and were not assessed. Unit of Measure: score on a scale
Time frame: 1 month (end of intervention)
Adherence to Homemade Kefir Consumption, Measured as the Percentage of Prescribed Daily Doses Consumed and Recorded in a Self-Report Log, Over 1 Month
Adherence was assessed in participants allocated to the whole-milk or skim-milk kefir groups using a self-report log. Each day, participants recorded whether the prescribed daily dose was consumed or not consumed. The prescribed dose escalated over the first three days (50 mL on day 1, 100 mL on day 2 and 150 mL on day 3) and was then 200 mL/day from day 4 until the end of the intervention. Adherence was calculated as the number of daily doses consumed divided by the total number of prescribed daily doses, multiplied by 100. Scores range from 0% (minimum) to 100% (maximum). Higher percentages indicate greater adherence, which is a better outcome. Adequate adherence was defined as consuming at least 80% of the prescribed daily doses. Adherence was compared between the homemade whole-milk kefir group and the homemade skim-milk kefir group. Participants in the standard dietary counseling group did not consume kefir and were not assessed. Unit percentage of prescribed daily doses
Time frame: From day 1 to 1 month (entire intervention period)
Incidence of adverse events
Adverse events were recorded weekly throughout the intervention in participants allocated to the whole-milk or skim-milk kefir groups. Gastrointestinal adverse events included bloating, flatulence, abdominal pain or cramping, nausea and diarrhea. Any other adverse event reported by participants was also recorded. Each event was classified by severity (mild, moderate or severe) and by its relationship to kefir consumption (related or not related). The number and percentage of participants with at least one adverse event, overall, by type of event, by severity and by relationship to kefir, were compared between the homemade whole-milk kefir group and the homemade skim-milk kefir group. Adverse events were not recorded in the standard dietary counseling group, because its participants did not receive kefir. Unit of Measure: participants
Time frame: Weekly, from day 1 to 1 month (entire intervention period)
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 243 non-industry interventional studies with no phase under Constipation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 7 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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