A pilot study evaluating the safety of vaginal administration of a multi-particulate pellet formulation.
OBJECTIVE
Quantitative evaluation of the effect caused by vaginal administration of gelatin capsules loaded with starch pellets and lyophilized powder, respectively, on vaginal pH and microflora.


METHODS
Administration of gelatin capsules loaded with fast-disintegrating starch pellets (group P) or lyophilized lactose/skimmed milk (group L) was compared to no intervention (group C) in a 3-way randomized, double-blinded, parallel study with 18 volunteers. Follow-up visits were at day 6 (immediately after administration), day 14 (pill stop), day 22 (after withdrawal bleeding) and day 35 (midcycle). Vaginal pH was measured and swabs were taken for Gram staining and culture to assess the presence of hydrogen peroxide-producing lactobacilli. Colposcopy was performed to assess the occurrence of adverse effects on the vaginal and ectocervical mucosa.


RESULTS
No severe adverse events occurred. For all women, vaginal pH and Gram stain were normal from screening until pill stop. Although immediately after withdrawal bleeding, 8 out of 18 women had an elevated pH, a disturbed microflora or lacked hydrogen peroxide-producing lactobacilli, all women had hydrogen peroxide-producing lactobacilli and a normal vaginal pH at midcycle, and all but two had a normal Gram stain.


CONCLUSIONS
No major differences could be observed between the groups, whereby all changes in pH and microflora could be ascribed to withdrawal bleeding, indicating that gelatin capsules, starch pellets and lyophilized powder are acceptable carrier materials for the vaginal delivery of probiotic strains.
Santiago
Guido Lopes Dos Santos
GL
Laboratory of Bacteriology Research (LBR), Ghent University, Ghent, Belgium.
Verstraelen
Hans
H
Poelvoorde
Nele
N
De Corte
Steven
S
Claeys
Geert
G
Trog
Marijke
M
De Backer
Ellen
E
Saerens
Bart
B
Vervaet
Chris
C
De Boeck
Fabienne
F
Van Bortel
Lucas
L
Remon
Jean-Paul
JP
Temmerman
Marleen
M
Vaneechoutte
Mario
M
Verhelst
Rita
R
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000818:Animals; D002214:Capsules; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004311:Double-Blind Method; D004337:Drug Carriers / Q000737:chemistry*; D005260:Female; D005500:Follow-Up Studies; D005612:Freeze Drying; D005780:Gelatin / Q000737:chemistry; D005840:Gentian Violet; D006801:Humans; D006861:Hydrogen Peroxide / Q000378:metabolism; D006863:Hydrogen-Ion Concentration; D007778:Lactobacillus / Q000378:metabolism; D007785:Lactose / Q000737:chemistry; D008597:Menstrual Cycle / Q000378:metabolism; D008875:Middle Aged; D008892:Milk / Q000737:chemistry; D010619:Phenazines; D010865:Pilot Projects; D013213:Starch / Q000737:chemistry*; D014621:Vagina / Q000187:drug effects* / Q000378:metabolism; D055815:Young Adult
D002214:Capsules; D004337:Drug Carriers; C035863:Gram's stain; D010619:Phenazines; D005780:Gelatin; D013213:Starch; D006861:Hydrogen Peroxide; D007785:Lactose; D005840:Gentian Violet