Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score).

The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales.

All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score.

Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score)

The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires.

The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items).

A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items.

Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation).

Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions.

Assessed using single question dichotomous tool.

Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation.

Participants will record the number of defecations per day in a daily diary

Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form.

Bristol Stool Scale:

The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5.

Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale.

The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining.

Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous "yes" or "no" scale.

The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2.

Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale.

The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining.

Severity of bloating will be recorded each day in a daily diary on a 5-point scale.

The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining.

Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale.

The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement.